[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Notices]
[Pages 1169-1171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-6085]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; General Administrative Practice and Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection associated with our 
General Administrative Practice and Procedures regulations.

DATES: Submit either electronic or written comments on the collection 
of information by March 9, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 9, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 9, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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 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-2019-N-6085 for ``General Administrative Practice and Procedures.'' 
Received comments, those filed in a timely manner (see ADDRESSES), 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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.

[[Page 1170]]


FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``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 concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites 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 to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

General Administrative Practice and Procedures

OMB Control Number 0910-0191--Revision

    This information collection supports FDA regulations governing its 
administrative practices and procedures. Although certain information 
collection pertaining to official administrative actions is not subject 
to review by OMB under the PRA in accordance with 44 U.S.C. 
3518(c)(1)(B) (5 CFR 1320.4(a)(2)), we have reviewed our regulations 
and are revising this information collection to include provisions that 
we believe may be subject to OMB review. We are also revising the 
information collection to consolidate related activities discussed in 
Agency guidance, as we believe this will improve the efficiency of our 
operations.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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10.19; request for waiver,                     1               1               1               1               1
 suspension, or modification of
 requirements...................
10.30 and 10.31; citizen                     220               1             220              24           5,280
 petitions and petitions related
 to ANDA,\2\ certain NDAs,\3\ or
 certain BLAs \4\...............
10.33; administrative                          6               1               6              10              60
 reconsideration of action......
10.35; administrative stay of                  6               1               5              10              50
 action.........................
10.65; meetings and                          750               1             750               5           3,750
 correspondence.................
10.85; requests for Advisory                   4               1               4              16              64
 opinions.......................
10.115(f)(3); submitting draft               100               1             100               4             400
 guidance proposals.............
12.22--Filing objections and                   5               1               5              20             100
 requests for a hearing on a
 regulation or order............
12.45--Notice of participation..               5               1               5               3              15
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    Total.......................  ..............  ..............           1,096  ..............           9,720
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Abbreviated New Drug Applications.
\3\ New Drug Applications.
\4\ Biologic License Applications.

    Unless a waiver, suspension, or modification submitted under Sec.  
10.19 (21 CFR 10.19) is granted by the Commissioner of Food and Drugs 
(the Commissioner), the regulations in 21 CFR part 10 apply to all 
petitions, hearings, and other administrative proceedings and 
activities conducted by FDA. Because we have not received requests 
under Sec.  10.19, we had not included this provision in the 
information collection. However, to reflect the attendant burden 
resulting from submitting such a request, we provide an estimate of 1 
response and 1 burden hour annually.
    Administrative proceedings may be initiated under Sec.  10.25 when 
a petition is submitted. Section 10.30 sets forth procedures by which 
an interested person may submit a citizen petition requesting the 
Commissioner to issue, amend, or revoke a regulation or order, or to 
take or refrain from taking any other form of administrative action. 
Similarly, section 10.31 governs citizen petitions and petitions for 
stay of action related to abbreviated new drug applications, certain 
new drug applications, or certain biologics license applications issued 
under section 701(a) of the Federal, Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 371(a)). The regulations provide content, format, and 
procedural requirements applicable to the submission of these 
petitions. To assist respondents to the information collection, FDA's 
Center for Drug Evaluation and Research developed an interpretive 
guidance entitled, ``Citizen Petitions and Petitions for Stay of Action 
Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic 
Act.'' The guidance describes FDA's current thinking on interpreting 
section 505(q) of the FD&C Act (21 U.S.C. 355(q)), and is currently 
approved under OMB control number 0910-0679. Based on Agency data, an 
average of 220 citizen petitions are received annually under Sec. Sec.  
10.30 and 10.31, and we estimate an average of 24 hours is required to

[[Page 1171]]

prepare such a petition, for a total of 5,280 hours annually.
    The regulations also establish a means by which an interested 
person may request that part or all of a decision by the Commissioner 
be reconsidered, or that the effective date of an action be stayed or 
extended. Sections 10.33 and 10.35 establish the content, format, and 
procedural requirements applicable to such requests and explain that 
they must be submitted no later than 30 days after the decision 
involved. The regulations provide alternatively that, for good cause, 
the Commissioner may permit a petition to be filed after 30 days. The 
regulations also explain that an interested person who wishes to rely 
on information or views not included in the administrative record shall 
submit them with a new petition to modify the decision. According to 
our records, we have received a total of 12 such requests and we assume 
it takes respondents an average of 10 hours to prepare.
    Section 10.65 covers Agency meetings and correspondence. Interested 
persons may hold meetings and exchange correspondence with FDA 
representatives on matters within its jurisdiction by following the 
instructions and providing the information described in Sec.  10.65. 
Because FDA maintains other information collections in its inventory 
that cover specific types of meeting requests, we did not previously 
include burden that may result from this section. However, to account 
for burden associated with meeting requests and correspondence 
generally, we provide an estimate of 2,000 submissions annually under 
this information collection; we assume one respondent per submission; 
and we assume each submission requires respondents anywhere between 1 
to 10 hours to prepare, including gathering and reviewing the necessary 
material. We therefore use an average of 5 hours for this estimate and 
base this estimate on our experience with similar information 
collection.
    Section 10.85, issued under section 701(a) of the FD&C Act, sets 
forth content, format, and procedural requirements by which an 
interested person may request an advisory opinion from the Commissioner 
on a matter of general applicability. The regulation explains that, 
when making a request, the petitioner must provide a concise statement 
of the issues and questions on which an opinion is requested, and a 
full statement of the facts and legal points relevant to the request. 
Based on Agency data, we estimate 4 such requests are received each 
year and we assume each request requires 16 hours to prepare, for a 
total of 64 hours annually.
    Section 10.115(f)(3) provides for the public submission of draft 
guidance documents or topics for development to our Dockets Management 
Staff. To participate in the development and issuance of guidance 
documents, the public may elect to submit comment through alternative 
mechanisms as explained in our Good Guidance Practice regulations under 
Sec.  10.115. Although most submissions and attendant burden associated 
with recommendations found in Agency guidance is accounted for in 
individual information collections associated with a particular product 
area or regulatory topic, here we are accounting for burden associated 
with general public submissions as described in Sec.  10.115(f)(3). 
Based on Agency data, we receive an average of 100 such submissions 
each year; we assume each submission requires an average of 4 hours to 
prepare; and therefore calculate a total burden of 400 hours annually.
    Regulations in 21 CFR 12.20 (Sec.  12.20) include information 
collection associated with requesting a formal evidentiary public 
hearing, and are issued under section 701(e)(2) of the FD&C Act. The 
regulations provide instructions for filing objections and requests for 
a hearing on a regulation or order under Sec.  12.20(d). Objections and 
requests must be submitted within the time specified in Sec.  12.20(e). 
Each objection, for which a hearing has been requested, must be 
separately numbered and specify the provision of the regulation or the 
proposed order. In addition, each objection must include a detailed 
description and analysis of the factual information and any other 
document, with some exceptions, supporting the objection. Failure to 
include this information constitutes a waiver of the right to a hearing 
on that objection. The description and analysis may be used only for 
the purpose of determining whether a hearing has been justified under 
21 CFR 12.24 and does not limit the evidence that may be presented if a 
hearing is granted. We estimate 5 respondents will file a request under 
the regulation and assume each request requires 20 hours to prepare, 
for a total of 100 hours annually.
    Finally, section 12.45 (21 CFR 12.45), issued under section 701 of 
the FD&C Act, sets forth content, format, and procedural requirements 
for any interested person to file a petition to participate in a formal 
evidentiary hearing, either personally or through a representative. 
Section 12.45 requires that any person filing a notice of participation 
state their specific interest in the proceedings, including the 
specific issues of fact about which the person desires to be heard. 
This section also requires that the notice include a statement that the 
person will present testimony at the hearing and will comply with 
specific requirements in 21 CFR 12.85, or, in the case of a hearing 
before a Public Board of Inquiry, concerning disclosure of data and 
information by participants (21 CFR 13.25). In accordance with Sec.  
12.45(e) the presiding officer may omit a participant's appearance. 
Based on our records, we estimate 5 filings under this regulation and 
assume it requires 3 hours to prepare, for a total of 15 hours 
annually.
    Respondents to the information collection are those interested 
persons conducting business with the FDA, and thus subject to the 
applicable administrative regulations.
    The burden estimates for this collection of information are based 
on Agency records and our experience over the past 3 years. By revising 
the information collection to include additional provisions, we have 
increased our annual burden estimate by 869 responses and 1,096 hours.

    Dated: January 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00151 Filed 1-8-20; 8:45 am]
 BILLING CODE 4164-01-P


