
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62509-62511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21725]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2241]


Substantiation for Structure/Function Claims Made in Infant 
Formula Labels and Labeling: Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Substantiation 
for Structure/Function Claims Made in Infant Formula Labels and 
Labeling.'' The draft guidance, when finalized, will describe the type 
and quality of evidence that we recommend that infant formula 
manufacturers and distributors have to substantiate structure/function 
claims in infant formula labels and labeling. This draft guidance is 
intended to help infant formula manufacturers making structure/function 
claims comply with the statutory requirement that all claims in infant 
formula labeling must be truthful and not misleading under the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act).

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10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
November 8, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 comments, that information will be posted on http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-D-2241 for ``Substantiation for Structure/Function Claims Made 
in Infant Formula Labels and Labeling.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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 http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition (HFS-800), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740. 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: 
    With regard to this draft guidance: Gillian Robert-Baldo, Center 
for Food Safety and Applied Nutrition (HFS-850), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1451.
    With regard to the information collection issues: Domini Bean, 
Office of Information Management, Food and Drug Administration, 1350 
Piccard Dr., PI50-400T, Rockville, MD 20850, domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Substantiation for Structure/Function Claims Made in Infant 
Formula Labels and Labeling.'' We are issuing this draft guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The draft guidance, when finalized, will represent our current

[[Page 62510]]

thinking on substantiation of structure/function claims in infant 
formula labels and labeling. 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.
    The draft guidance, when finalized, will describe the type and 
quality of evidence we recommend that infant formula manufacturers and 
distributors have in their records to substantiate their structure/
function claims in the labeling of infant formulas. It will describe 
what we believe to be competent and reliable scientific evidence to 
substantiate structure/function claims in the context of infant 
formulas.

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: Recommended Recordkeeping to Substantiate Structure/Function 
Claims Made in Infant Formula Labels and Labeling (OMB Control Number 
0910--NEW).
    Description of respondents: This new collection of information 
would be performed by infant formula manufacturers and distributors. 
The records recommended, to the extent practicable, in this draft 
guidance would include one-time and annual information collection 
burdens pertaining to substantiation of structure/function claims made 
by infant formula manufacturers and distributors. In addition, we have 
estimated the information collection burden for any future structure/
function claims that would involve controlled studies to generate data 
to support those structure/function claims.
    The draft guidance document for industry entitled ``Substantiation 
for Structure/Function Claims Made in Infant Formula Labels and 
Labeling'' addresses only structure/function claims in infant formula 
labeling. It describes the type and quality of evidence we recommend 
infant formula manufacturers and distributors have to substantiate 
their structure/function claims in labeling of both nonexempt and 
exempt infant formulas under section 403(a) of the FD&C Act (21 U.S.C. 
343(a)(1)).
    Analysis of Burden Estimates Resulting From Substantiation for 
Infant Formula Structure/Function Claims: Infant formula manufacturers 
and distributors would only collect information to substantiate their 
product's structure/function claim if they choose to place a structure/
function claim on their product's label or labeling. Gathering evidence 
on a currently existing claim is estimated to be a one-time burden; the 
respondents would collect the substantiating information for their 
product pursuant to section 403(a) of the FD&C Act. We recommend that 
infant formula manufacturers and distributors accurately maintain the 
substantiating materials for these claims in their files. We estimate 
that infant formula manufacturers and distributors would seek 
substantiation for their claims in intervention studies and the 
scientific literature and that this burden will likely be comparable to 
the time needed to assemble information for a new infant formula 
submission (16 hours). In addition, we estimate, based on information 
available to FDA, that there are currently 10 existing structure/
function claims for which infant formula manufacturers would gather 
substantiation data. Therefore, the total one-time estimated burden 
imposed by this collection of information would be 160 hours (16 
estimated information collection hours x 10 estimated existing 
structure/function claims), as shown in table 1.
    We have estimated the annual information collection burdens for 
maintenance of records related to substantiation of existing structure/
function claims. We estimate that respondents would spend 1 hour 
annually maintaining records for each of the 10 estimated currently 
existing structure/function claims. Therefore, 1 hour x 10 claims = 10 
annual hours, as presented in table 1.
    It is possible that an infant formula manufacturer or distributor 
would want to make a structure/function claim for which there is 
equivocal or insufficient evidence or no substantiating evidence. In 
this case, we estimate that an infant formula manufacturer or 
distributor would conduct a controlled study in order to gather data to 
substantiate the structure/function claim. It is not possible to know 
the frequency with which this may occur; however, we assume that an 
infant formula manufacturer or distributor would engage in a controlled 
study only if the benefits to the infant formula manufacturer or 
distributor were larger than the costs of performing the study. To 
account for the possibility that infant formula manufacturers or 
distributors would choose to conduct a controlled study for the purpose 
of generating data to substantiate a new structure/function claim, in 
table 2 we estimate an information collection burden based on one 
hypothetical annual controlled study. The burdens of this hypothetical 
controlled study are based on averages taken from three sample 
controlled studies (Refs. 1, 2, and 3) and estimates an average test 
subject size of 153 infants.
    We estimate that a hypothetical controlled study would involve, on 
average, four recordkeepers: A principal investigator (e.g., a 
physician), a sample collector, one nurse or other health care 
professional with similar experience, and a microbiological laboratory 
technologist. We estimate that the principal investigator would work, 
on average, 3 hours annually to assemble and interpret the data 
collected per study period. We estimate that one sample collector would 
work an average of 38.25 hours annually (153 infants x 0.25 hours per 
infant = 38.25 hours) to collect and record stool samples from infants. 
We estimate that one nurse or other health care professional with 
similar experience would work an average of 38.25 hours annually (153 
infants x 0.25 hours per infant = 38.25 hours) to complete 
questionnaires on the samples collected from the infants in the study. 
We estimate that a

[[Page 62511]]

microbiological laboratory technologist would work an average of 76.5 
hours annually (153 infants x 0.5 hours per infant = 76.5 hours) to 
prepare and analyze fecal samples taken from infants in the controlled 
study. All estimates are shown in table 2. Therefore, a total of 156 
additional annual burden hours (3 + 38.25 + 38.25 + 76.5 = 156) are 
estimated to account for the information collection burden resulting 
from the need to conduct a controlled study in order to gather data to 
substantiate a new structure/function claim, or a structure/function 
claim that lacks sufficient prior evidence, for a total of 166 total 
annual hours (156 + 10 = 166) for the upkeep and generation of 
information used to substantiate structure/function claims. Including 
the one-time burden of 160 hours annualized over 3 years (160/3 = 
53.3), the total annual record keeping burden is 219.3 hours (166 + 
53.3 = 219.3). There are no estimated capital costs or operating and 
maintenance costs associated with this information collection.

                             Table 1--Estimated One-Time Hourly Recordkeeping Burden
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                                                    First year
     Recordkeeping activity          Number of     frequency of    Total records     Hours per      Total hours
                                    respondents    recordkeeping                      record
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                                            First Year Hourly Burden
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Assembling Records Related to                 10               1              10              16             160
 Substantiation of Existing
 Structure/Function Claims......
                                 -------------------------------------------------------------------------------
    Total First Year Only         ..............  ..............  ..............  ..............            *160
     Recordkeeping Burden.......
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                                          Table 2--Recordkeeping Burden
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                                                    Annual
    Recordkeeping activity         Number of     frequency of    Total records  Hours per record    Total hours
                                  respondents    recordkeeping
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                                             Recurring Hourly Burden
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*Annualized Recordkeeping                   10               1             5.3  1...............            53.3
 Burden from Table 1.
Maintaining Records Related to              10               1              10  1...............              10
 Substantiation of Structure/
 Function Claims.
Controlled Study--Principal                  1               1               1  3...............               3
 Investigator.
Controlled Study--Sample                     1             153             153  0.25 (15                   38.25
 Collector.                                                                      minutes).
Controlled Study--Nurse/Heath                1             153             153  0.25 (15                   38.25
 Care Professional.                                                              minutes).
Controlled Study--Lab Tech....               1             153             153  0.5 (30 minutes)            76.5
                               ---------------------------------------------------------------------------------
    Total Recordkeeping Burden  ..............  ..............  ..............  ................           219.3
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    Before the proposed information collection provisions contained in 
this draft guidance become effective, we will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the proposed information collection provisions. An Agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://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 in the Division of Dockets 
Management (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 http://www.regulations.gov.

1. Moro, G., F. Mosca, V. Miniello, et al., ``Effects of a New 
Mixture of Prebiotics on Faecal Flora and Stools in Term Infants.'' 
Acta Paediatrica, 2003. Supplement September 1991(441): pp. 77-79.
2. Boehm, G., M. Lidestri, P. Casetta,, et al., ``Supplementation of 
a Bovine Milk Formula with an Oligosaccharide Mixture Increases 
Counts of Faecal Bifidobacteria in Preterm Infants.'' Archives of 
Disease in Childhood Fetal and Neonatal Edition, 2002. 86(3): pp. 
F178-181.
3. Pickering, L.K., D.M. Granoff, J.R. Erickson, et al., 
``Modulation of the Immune System by Human Milk and Infant Formula 
Containing Nucleotides.'' Pediatrics, 1998. 101(2): pp. 242-249.

    Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21725 Filed 9-8-16; 8:45 am]
 BILLING CODE 4164-01-P


