[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Proposed Rules]
[Pages 53433-53438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24845]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 170 and 570

[Docket No. FDA-2017-D-0085]


Best Practices for Convening a Generally Recognized as Safe 
Panel: Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Best Practices for Convening a GRAS Panel.'' This draft guidance 
document is intended for any person who is responsible for a conclusion 
that a substance may be used in food on the basis of the generally 
recognized as safe (GRAS) provision of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) when that person convenes a panel of 
experts (``GRAS panel'') to independently evaluate whether the 
available scientific data, information, and methods establish that the 
substance is safe under the conditions of its intended use in human 
food or animal food. This draft guidance provides our current thinking 
on best practices to identify GRAS panel members who have appropriate 
and balanced expertise; to take steps to reduce the risk that bias (or 
the appearance of bias) will affect the credibility of the GRAS panel's 
output (often called a ``GRAS panel report''), including the assessment 
of potential GRAS panel members for conflict of interest and the 
appearance of conflict of interest; and to limit the data and 
information provided to a GRAS panel to public information (e.g., by 
not providing the GRAS panel with information such as trade secret 
information).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we issue the final version of the guidance, submit 
either electronic or written comments by May 15, 2018. For comments 
related to the collection of information provisions in this draft 
guidance, submit either electronic or written comments by January 16, 
2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your

[[Page 53434]]

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-0085 for ``Best Practices for Convening a GRAS Panel.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.''
    Any information marked as ``confidential'' will not be disclosed 
except in accordance with 21 CFR 10.20 and other applicable disclosure 
law. For more information about FDA's posting of comments to public 
dockets, see 80 FR 56469, September 18, 2015, or access the information 
at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
Office of Food Additive Safety, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration (HFS-200), 5001 Campus Dr., 
College Park, MD 20740 or to the Office of Surveillance and Compliance 
(HFV-200), 7519 Standish Pl., Rockville, MD 20855. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Regarding substances that would be 
used in human food: Paulette M. Gaynor, Center for Food Safety and 
Applied Nutrition (HFS-255), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1192. Regarding substances that 
would be used in animal food: Geoffrey K. Wong, Center for Veterinary 
Medicine (HFV-224), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5838. Regarding the information collection 
issues: FDA PRA Staff, Office of Operations, Food and Drug 
Administration, Three White Flint North, 10A63, 11601 Landsdown St., 
North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) defines a ``food 
additive'' as any substance the intended use of which results or may 
reasonably be expected to result, directly or indirectly, in its 
becoming a component or otherwise affecting the characteristics of any 
food if such substance is not generally recognized, among experts 
qualified by scientific training and experience to evaluate its safety, 
as having been adequately shown through scientific procedures (or, in 
the case of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use in food) 
to be safe under the conditions of its intended use. Under this 
definition, a substance that is GRAS under the conditions of its 
intended use is not a ``food additive'' and is therefore not subject to 
mandatory premarket review by FDA under section 409 of the FD&C Act (21 
U.S.C. 348). In this document, we refer to a person who is responsible 
for a conclusion that a substance may be used in human food or animal 
food on the basis of the GRAS provision of the FD&C Act, without 
premarket review by FDA under section 409 of the FD&C Act, as the 
``proponent'' of that substance.
    We have established regulations implementing the GRAS provision of 
section 201(s) of the FD&C Act in part 170 (21 CFR part 170) for human 
food and in part 570 (21 CFR part 570) for animal food. Those 
regulations include a voluntary procedure (``GRAS notification 
procedure'') through which a proponent may notify us of a conclusion 
that a substance is GRAS under the conditions of its intended use in 
human food (part 170, subpart E) or animal food (part 570, subpart E). 
Under the interim pilot program, we have filed and responded to more 
than 600 GRAS notices for substances intended for use in human food and 
18 GRAS notices for substances intended for use in animal food (80 FR 
54960 at 54964, August 17, 2016).
    In some cases, the process whereby the proponent evaluates whether 
the available data and information support a conclusion that a 
substance is GRAS under the conditions of its intended use includes 
considering the opinion of a ``GRAS panel'' of qualified experts who 
independently evaluate whether the available scientific data, 
information, and methods establish that a substance is safe under the 
conditions of its intended use in human food or animal food. Depending 
on the outcome of the GRAS panel's analysis, the proponent could either 
reach a conclusion regarding the safety of the substance under the 
conditions of its intended use, or be advised of one or more issues 
(such as gaps in the data and information, or alternative 
interpretations of the available data and information) that warrant 
investigation before a conclusion can be drawn about whether the 
substance is safe under the conditions of its intended use. When the 
outcome of the GRAS panel's analysis supports the proponent's 
conclusion that a substance is safe under the conditions of its 
intended use, in essence the proponent then relies on the members of 
the GRAS panel to act as a proxy for the larger scientific community 
knowledgeable about the safety of substances directly or

[[Page 53435]]

indirectly added to food and, in so doing, relies on the outcome of the 
GRAS panel's analysis to support the proponent's conclusion that the 
safety of the intended use is ``generally recognized'' by qualified 
experts. Whether a GRAS panel is a sufficient proxy for the larger 
scientific community depends on a number of factors, such as the 
subject matter expertise of the members of the GRAS panel and whether 
the members of the GRAS panel would be considered representative of 
experts qualified by scientific training and experience to evaluate the 
safety of the substance under the conditions of its intended use.
    A GRAS panel is one mechanism that proponents have used to 
demonstrate that the safety of a substance under the conditions of its 
intended use is generally recognized by qualified experts. However, the 
use of a GRAS panel is not the only mechanism for doing so and the use 
of a GRAS panel does not necessarily mean that the GRAS criteria have 
been met (81 FR 54960 at 54974-54975, August 17, 2016).
    We are announcing the availability of a draft guidance for industry 
entitled ``Best Practices for Convening a GRAS Panel.'' We are issuing 
the draft guidance consistent with our good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent the current thinking of FDA on this topic. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations. This is not a 
significant regulatory action subject to Executive Order 12866.
    This draft guidance document is intended for any proponent who 
convenes a GRAS panel and provides our current thinking on best 
practices to identify GRAS panel members who have appropriate and 
balanced expertise; to take steps to reduce the risk that bias (or the 
appearance of bias) will affect the credibility of a GRAS panel report, 
including the assessment of potential GRAS panel members for conflict 
of interest and the appearance of conflict of interest; and to limit 
the data and information provided to a GRAS panel to public information 
(e.g., by not providing the GRAS panel with information such as trade 
secret information).

II. Paperwork Reduction Act of 1995

    This draft guidance contains proposed information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520). ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, we invite comments on these topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information collected; and (4) 
ways to minimize the burden of the information collected on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    Title: Best Practices for Convening a GRAS Panel (OMB control 
number 0910--NEW).
    Description of respondents: This new collection of information 
would be performed by those persons (``proponents'') who are 
responsible for a conclusion that a substance may be used in food on 
the basis of the GRAS provision of the FD&C Act when such persons 
convene a GRAS panel to independently evaluate whether the available 
scientific data, information, and methods establish that the substance 
is safe under the conditions of its intended use in human food or 
animal food. The records recommended in this draft guidance would 
include a one-time information collection burden pertaining to a 
written GRAS panel policy to govern the assembly and conduct of a GRAS 
panel. The records recommended in this draft guidance also would 
include annual information collection burdens pertaining to documenting 
the application of the written GRAS panel policy to each member of a 
GRAS panel convened in a given year. Finally, the draft guidance 
recommends that a GRAS panel provide a written report of its findings; 
however, we consider that a written GRAS panel report is customary 
business practice that is already being created by GRAS panels and, 
thus, we do not estimate an annual information collection burden for 
the creation of a GRAS panel report.
    Analysis of Burden Estimates Resulting from the Recommendation for 
a Written GRAS Panel Policy: For the purpose of this analysis, we make 
the conservative assumption that all proponents who document a GRAS 
conclusion will create a written GRAS panel policy that would apply to 
GRAS panels convened in the first year that the draft guidance, if 
finalized, would be in effect as well as to GRAS panels convened in 
subsequent years. We also assume that these proponents will create a 
written GRAS panel policy regardless of whether they report the 
documented GRAS conclusion to FDA in the form of a GRAS notice. 
Therefore, for the purpose of this analysis we: (1) Calculated the 
number of proponents who have submitted at least one GRAS notice to FDA 
and (2) estimated the number of proponents who have documented at least 
one GRAS conclusion without reporting that documented GRAS conclusion 
to FDA in the form of a GRAS notice.
    Using the data in our inventories of GRAS notices submitted for 
substances intended for use in human food (Ref. 1) and animal food 
(Ref. 2) during the time period of April 17, 1997, through September 5, 
2017, we calculate that 396 proponents submitted at least one GRAS 
notice for a substance intended for use in human food, and 15 
proponents submitted at least one GRAS notice for a substance intended 
for use in animal food. During that time period, there were three 
proponents who had submitted at least one GRAS notice for a substance 
intended for use in human food and at least one GRAS notice for a 
substance intended for use in animal food. However, for the purpose of 
this analysis, we make the conservative assumption that there will be 
no overlap between proponents who submit GRAS notices for substances 
intended for use in human food and proponents who submit GRAS notices 
for substances intended for use in animal food. Therefore, the total 
number of proponents who have submitted at least one GRAS notice to FDA 
is 411 (396 proponents + 15 proponents = 411 proponents).
    We have very little information about the number of proponents who 
have documented a GRAS conclusion without reporting that GRAS 
conclusion to FDA in the form of a GRAS notice. To estimate the number 
of such proponents, we used a publicly

[[Page 53436]]

available database entitled ``Independent GRAS (Generally Recognized As 
Safe) Conclusion Inventory Database'' (Ref. 3), which is a compilation 
of the results of a consulting company's search of publicly available 
information in industry trade journals about documented GRAS 
conclusions for substances intended for use in human food. The oldest 
entry is for the year 1995. FDA received the first GRAS notice for 
substances intended for use in human food in 1998 and, thus, the 
database covers the entire timeframe during which FDA has been 
receiving GRAS notices for substances intended for use in human food. 
As of September 5, 2017, that database recorded that there had been a 
total of 199 documented GRAS conclusions, with 41 of those documented 
GRAS conclusions reported to FDA as a GRAS notice and 158 of those 
documented GRAS conclusions not reported to FDA as a GRAS notice. In 
contrast, as of September 5, 2017, FDA's inventory of GRAS notices 
shows that the number of GRAS conclusions reported to FDA during this 
timeframe was 720, not 41 (Ref. 1). We assume that the reduced number 
of documented GRAS conclusions that the database recorded as being 
reported to FDA is due to the mechanism by which the database searches 
for documented GRAS conclusions (i.e., publications in industry trade 
journals). For example, there could be less incentive for a business 
that reports its documented GRAS conclusion to FDA to publicize that 
GRAS conclusion through industry trade journals, because the business 
can publicize FDA's response to the GRAS notice in other ways.
    The database attributes the 158 documented GRAS conclusions not 
reported to FDA to 142 different proponents. However, 62 of these 
proponents have also submitted a GRAS notice to FDA and, thus, we 
calculate that the database attributes documented GRAS conclusions to 
80 proponents who have not submitted a GRAS notice to FDA (142 
proponents listed in the database--62 proponents who we already counted 
because they submitted a GRAS notice to FDA). We also make the 
conservative assumption that the number of proponents who have 
documented GRAS conclusions without reporting them to FDA since FDA 
began receiving GRAS notices is twice as high as recorded in the 
database--i.e., 160 proponents (80 proponents listed in the database x 
2 = 160).
    The publicly available database does not record documented GRAS 
conclusions for substances intended for use in animal food. However, 
based on the number of annual GRAS notices submitted to FDA in recent 
years, we previously estimated that the number of annual GRAS notices 
submitted to FDA for substances intended for use in animal food would 
be 50 percent of the number of annual GRAS notices submitted to FDA for 
substances intended for use in human food (i.e., we estimated 50 GRAS 
notices will be submitted to FDA annually for substances intended for 
use in human food and that 25 GRAS notices will be submitted to FDA 
annually for substances intended for use in animal food (OMB control 
number 0910-0342; 81 FR 54960)). Therefore, for the purpose of this 
analysis we assume that the number of proponents who have documented 
GRAS conclusions for substances intended for use in animal food without 
reporting those GRAS conclusions to FDA is 50 percent of the number of 
proponents who documented GRAS conclusions for substances intended for 
use in human food without reporting those GRAS conclusions to FDA--
i.e., 80 proponents (160 estimated proponents who have documented GRAS 
conclusions without reporting those GRAS conclusions to FDA x 0.5 = 80 
proponents). We calculate that the total number of proponents who 
documented GRAS conclusions without reporting those GRAS conclusions to 
FDA is 240 proponents (160 estimated proponents who have documented 
GRAS conclusions for substances intended for use in human food + 80 
estimated proponents who have documented GRAS conclusions for 
substances intended for use in animal food = 240 proponents).
    To estimate the total number of proponents, we are adding 240 
estimated proponents who have not reported their documented GRAS 
conclusions to FDA to the 411 proponents who have already submitted at 
least one GRAS notice to FDA for a total of 651 proponents who will 
document a GRAS conclusion (240 non-reporting proponents + 411 
reporting proponents = 651 total proponents). As already stated, for 
the purpose of this analysis we make the conservative assumption that 
all of these proponents who document GRAS conclusions (i.e., 651 
proponents) will create a written GRAS panel policy. We estimate that 
it would take 40 hours to create a written GRAS panel policy, including 
8 hours to review relevant, publicly available policies (e.g., Refs. 4 
and 5) that address conflict of interest and 32 hours to tailor a GRAS 
panel policy specific to the proponent, using relevant information from 
such existing policies as appropriate to the needs of the proponent. As 
shown in table 1, the total one-time burden to create a written GRAS 
panel policy is 40 hours per proponent x 651 proponents = 26,040 hours. 
We request comment on our estimate of the total number of proponents 
and on the hourly burden to create a written GRAS panel policy. There 
are no estimated capital costs or operating and maintenance costs 
associated with the information collection for a written GRAS panel 
policy.
    Analysis of Burden Estimates Resulting From the Recommendation for 
Application of a Written GRAS Panel Policy to GRAS Panel Members: Based 
on the number of annual GRAS notices submitted to FDA in recent years, 
we previously estimated that 50 GRAS notices will be submitted to FDA 
for substances intended for use in human food and that 25 GRAS notices 
will be submitted to FDA for substances intended for use in animal food 
(OMB control number 0910-0342; 81 FR 54960), for a total number of 75 
GRAS notices submitted to FDA each year. We count each GRAS notice as a 
single GRAS conclusion, and, for the purpose of this analysis, we 
assume that a different proponent submits each of these GRAS notices. 
Therefore, we estimate that the total number of documented GRAS 
conclusions submitted to FDA on an annual basis is 75 GRAS conclusions 
and that these GRAS conclusions are submitted by 75 proponents.
    We have not previously estimated the annual number of documented 
GRAS conclusions that are not reported to FDA as a GRAS notice. For the 
purpose of this analysis, to estimate such GRAS conclusions we used the 
same database (Ref. 3) that we used to estimate the total number of 
proponents who document GRAS conclusions without reporting the GRAS 
conclusions to FDA in the form of a GRAS notice. As already stated, the 
oldest recorded entry in the database is for the year 1995. However, 
with the exception of that single entry for 1995, the remaining entries 
are for the years 2001 and beyond. In addition, the current year (2017) 
has not reached its end. Therefore, we use 16 years (i.e., from 2001 
through 2016) as the number of years covering those documented GRAS 
conclusions that are not reported to FDA. For the purpose of 
calculating the annual number of documented GRAS conclusions that are 
for substances intended for use in human food but not reported to FDA, 
we estimate that there are 157 such GRAS conclusions (158 documented, 
unreported GRAS conclusions for

[[Page 53437]]

substances intended for use in human food minus 1 GRAS conclusion 
reported before 2001). We calculate that, on average, the annual number 
of documented, unreported GRAS conclusions for substances intended for 
use in human food and recorded in the database is 10 (157 documented, 
unreported GRAS conclusions/16 years = 9.8 documented, unreported GRAS 
conclusions per year recorded in the database, rounded up to 10). As 
with our analysis of the total number of proponents, we conservatively 
assume that the annual number of documented, unreported GRAS 
conclusions for substances intended for use in human food could be 
twice as high as the annual number of documented, unrecorded GRAS 
conclusions recorded in the database--i.e., 20 documented, unreported 
GRAS conclusions for substances intended for use in human food each 
year (10 documented, unreported GRAS conclusions recorded in the 
database on an annual basis x 2 = 20 documented, unreported GRAS 
conclusions on an annual basis). As with documented GRAS conclusions 
that are reported to FDA, we assume that a different proponent is 
responsible for each documented GRAS conclusion not reported to FDA 
and, thus, on an annual basis there are 20 proponents who do not report 
their documented GRAS conclusions for substances intended for use in 
human food to FDA. As with our analysis of the total number of 
proponents, we conservatively assume that the annual number of 
documented, unreported GRAS conclusions for substances intended for use 
in animal food is 50 percent of the annual number of documented, 
unreported GRAS conclusions for substances intended for use in human 
food--i.e., 10 documented, unreported GRAS conclusions for substances 
intended for use in animal food on an annual basis (20 documented, 
unreported GRAS conclusions for substances intended for use in human 
food x 0.5). We therefore calculate that there is a total of 30 
documented, unreported GRAS conclusions each year (20 documented, 
unreported GRAS conclusions for substances intended for use in human 
food + 10 documented, unreported GRAS conclusions for substances 
intended for use in animal food). We also calculate that there are 105 
proponents who document a GRAS conclusion on an annual basis (75 
proponents who report their documented GRAS conclusions to FDA as a 
GRAS notice + 30 proponents who do not report their documented GRAS 
conclusions to FDA as a GRAS notice = 105 total proponents).
    We have information about the percent of proponents who convene a 
GRAS panel for a documented GRAS conclusion and also submit a GRAS 
notice to FDA. During the time period April 17, 1997, through September 
5, 2017, on average, 63 percent of proponents who submitted a GRAS 
notice for a substance intended for use in human food, and 60 percent 
of proponents who submitted a GRAS notice for a substance intended for 
use in animal food, convened a GRAS panel. We therefore estimate that, 
on an annual basis, 32 proponents will convene a GRAS panel and submit 
a GRAS notice to FDA for substances intended for use in human food (63 
percent x 50 proponents = 31.5 proponents; rounded up to 32 
proponents), and 15 proponents will convene a GRAS panel and submit a 
GRAS notice to FDA for substances intended for use in animal food (60 
percent x 25 proponents = 15 proponents). We calculate that the total 
number of proponents who will convene a GRAS panel and submit a GRAS 
notice to FDA is 47 proponents (32 proponents who submit GRAS notices 
for substances intended for use in human food + 15 proponents who 
submit GRAS notices for substances intended for use in animal food = 47 
proponents). We also assume that all proponents will document the 
application of a written GRAS panel policy to each member of the GRAS 
panel.
    We have very little information about the percent of proponents who 
convene a GRAS panel for a documented GRAS conclusion but do not report 
their documented GRAS conclusions to FDA as a GRAS notice. For the 
purpose of this analysis, we make the conservative assumption that all 
30 proponents who annually document GRAS conclusions without reporting 
them to FDA will convene a GRAS panel. Taking into account the 
estimated number of proponents who convene a GRAS panel and submit a 
GRAS notice to FDA, and the estimated number of proponents who convene 
a GRAS panel but do not submit a GRAS notice to FDA, we calculate that 
the total number of proponents who will convene a GRAS panel and 
document the application of the written GRAS panel policy to each 
member of a GRAS panel on an annual basis is 77 proponents (47 
proponents who submit GRAS notices to FDA+ 30 proponents who do not 
submit GRAS notices = 77 proponents).
    Based on the recommendations in the draft guidance, if finalized, 
we assume that all GRAS panels will include at least 3 panel members 
(with expertise in chemistry or biochemistry, toxicology, and exposure 
assessment) and that some GRAS panels will include as many as 6 panel 
members with expertise that reflects the physical, chemical, and 
biological properties of the substance and the scientific questions 
that arise in relation to the conditions of its intended use. We assume 
that a GRAS panel will include 5 panel members on average. We also 
assume that the proponent will reject at least one individual with 
applicable expertise due to a financial conflict of interest or the 
appearance of a financial or non-financial conflict of interest and, 
thus, that 77 proponents will document the application of the written 
GRAS panel policy to 6 individual GRAS panel members, for a total of 
462 documentations by proponents of the application of the written GRAS 
panel policy (77 proponents x 6 individual panel members = 462 
documentations). As shown in table 2, we estimate that it will take 16 
hours to document the application of the written GRAS policy to each 
panel member, for a total of 7,392 hours (462 documentations x 16 hours 
per documentation = 7,392 hours). As shown in table 3, we assume that 
all 462 individuals who are being considered as members of a GRAS panel 
will each need 4 hours to provide applicable information to the 
proponent, for a total of 1,848 hours (462 individuals x 4 hours per 
individual = 1,848 hours).
    There are no estimated capital costs or operating and maintenance 
costs associated with this information collection for the application 
of a written GRAS panel policy to individuals being considered as 
members of a GRAS panel.

[[Page 53438]]



                                                  Table 1--Estimated One-Time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                         Average burden
                                                                        Number of        Number of       Total annual         per
                           Recommendation                             recordkeepers     records per        records       recordkeeping     Total hours
                                                                                        recordkeeper                       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written GRAS panel policy..........................................             651                1              651               40           26,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                         Average burden
                                                                        Number of        Number of       Total annual         per
                           Recommendation                             recordkeepers     records per        records       recordkeeping     Total hours
                                                                                        recordkeeper                       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application of written GRAS panel policy to GRAS panel members.....              77                6              462               16            7,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                         Average burden
                                                                        Number of        Number of       Total annual         per
                           Recommendation                             recordkeepers     records per        records       recordkeeping     Total hours
                                                                                        recordkeeper                       (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information provided by potential GRAS panel members to the                     462                1              462                4            1,848
 proponents of GRAS conclusions....................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

IV. References

    The following references are on display with the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA (2017). GRAS Notices. Available at https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices.
2. FDA (2017). Current Animal Food GRAS Notices Inventory. Available 
at https://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/GenerallyRecognizedasSafeGRASNotifications/ucm243845.htm.
3. AIBMR Life Sciences, Inc. (2017). Independent GRAS (Generally 
Recognized As Safe) Conclusion Inventory Database. Available at 
http://aibmr.com/natural-products-industry-compliance-consultation/gras-generally-recognized-as-safe-safety-studies/.
4. Institute of Medicine (2009). Full Report. Conflict of Interest 
in Medical Research, Education, and Practice. National Academies 
Press, 500 5th Street NW., Lockbox 285, Washington, DC 20055. 
Available at https://www.nap.edu/catalog/12598/conflict-of-interest-in-medical-research-education-and-practice.
5. The National Academies of Sciences, Engineering, and Medicine 
(2003). Conflicts of Interest Policy for Committees Used in the 
Development of Reports. The National Academies Press, 500 5th Street 
NW., Washington, DC 20001. Available at http://www.nationalacademies.org/coi/.

    Dated: November 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24845 Filed 11-15-17; 8:45 am]
 BILLING CODE 4164-01-P


