[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7981-7982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02500]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0134]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Administrative Practices and Procedures; Formal 
Hearings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 general FDA administrative practices and procedures, 
including requests for formal hearings.

DATES: Either electronic or written comments on the collection of 
information must be submitted by April 10, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 10, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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-2023-N-0134 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Administrative Practices and 
Procedures; Formal Hearings.'' 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, 240-402-7500.
     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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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,

[[Page 7982]]

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.

FDA Administrative Practices and Procedures; Formal Hearings

OMB Control No. 0910-0191--Extension

    This information collection supports FDA regulations found in part 
10 (21 CFR part 10), parts 12 through 16 (21 CFR parts 12 through 16), 
and part 19 (21 CFR part 19). These regulations are established in 
accordance with the Administrative Procedures Act (5 U.S.C. subchapter 
11) and implement administrative practice and procedures to give 
instructions to those conducting business with FDA. Regulations in part 
10 describe general administrative practices and include content and 
format instruction on submitting information to the Agency, petitions 
for Agency action, and other topics such as the public calendar. 
Regulations in parts 12 through 16 cover formal evidentiary, public, 
and regulatory hearings. The information collection also includes 
burden associated with waiver requests under Sec.  10.19 (21 CFR 
10.19). Unless a waiver, suspension, or modification submitted under 
Sec.  10.19 is granted by the Commissioner of Food and Drugs, the 
regulations in part 10 apply to all petitions, hearings, and other 
administrative proceedings and activities conducted by FDA. Because 
information associated with regulations in parts 12 through 16 is 
obtained during the conduct of an official administrative action as 
described under 5 CFR 1320.4, we account only for burden we attribute 
to initiating the respective actions.
    The information collection also includes burden associated with 
general meeting requests and correspondence submitted to FDA under 
Sec.  10.65 (21 CFR 10.65), as well as general submissions associated 
with Sec.  10.115 (21 CFR 10.115) which provides for public 
participation in the development of Agency guidance documents through 
requests to our Dockets Management Staff. Most burden attributable to 
recommendations found in FDA guidance documents is accounted for within 
information collection request (ICR) approvals respective to the topic-
specific guidance document; however here we are accounting for burden 
associated with general public submissions as described in Sec.  
10.115(f)(3).
    The information collection also includes burden that may be 
associated with the procedural guidance document, ``Citizen Petitions 
and Petitions for Stay of Action Subject to Section 505(q) of the 
Federal Food, Drug, and Cosmetic Act'' (September 2019), available for 
download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/citizen-petitions-and-petitions-stay-action-subject-section-505q-federal-food-drug-and-cosmetic-act. The guidance document provides information regarding our 
current thinking on interpreting section 505(q) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(q)) and includes procedural 
instruction on submitting certain citizen petitions and petitions for 
stay of FDA action. The guidance document also describes how FDA 
interprets the provisions of section 505(q) requiring that (1) a 
petition include a certification and (2) supplemental information or 
comments on a petition include a verification. It also addresses the 
relationship between the review of petitions and pending ANDAs, 
505(b)(2) applications, and 351(k) applications for which a decision on 
approvability has not yet made.
    We estimate the burden of the information collection 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,                     7               1               7               1               7
 suspension, or modification of
 requirements...................
10.30 and 10.31--citizen                     200               1             200              24           4,800
 petitions and petitions related
 to ANDA,\2\ certain NDAs,\3\ or
 certain BLAs \4\...............
10.33--administrative                          9               1               9              10              90
 reconsideration of action......
10.35--administrative stay of                 12               1              12              10             120
 action.........................
10.65--meetings and                           37               1              37               5             185
 correspondence.................
10.85--requests for Advisory                   1               1               1              16              16
 opinions.......................
10.115(f)(3)--submitting draft                26               1              26               4             104
 guidance proposals.............
12.22--Filing objections and                  18               1              18              20             360
 requests for a hearing on a
 regulation or order............
12.45--Notice of participation..               5               1               5               3              15
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    Total.......................  ..............  ..............  ..............  ..............           5,697
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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.

    Based on submissions to FDA's Division of Dockets Management since 
our last evaluation of the information collection, we have made 
adjustments to burden estimates associated with the individual 
activities that correspond to the applicable provisions. As a result, 
the information collection reflects a decrease of 4,223 annual burden 
hours.

    Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02500 Filed 2-6-23; 8:45 am]
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