[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38057-38058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Administrative 
Practices and Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by July 12, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0191. Also include the FDA docket 
number found in brackets in the heading of this document.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

FDA Administrative Practices and Procedures

OMB Control No. 0910-0191--Revision

    This information collection helps support implementation of 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 II) 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 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 abbreviated 
new drug applications (ANDAs), 505(b)(2) applications, and 351(k) 
applications for which a decision on approvability has not yet been 
made.
    In the Federal Register of February 7, 2023 (88 FR 7981), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received. On our own 
initiative, however we are revising the information collection to 
include requests for FDA speakers. As communicated on our website at 
https://www.fda.gov/training-and-continuing-education/contacts-requesting-fda-speaker, FDA receives thousands of requests each year 
from trade associations and industry-based groups for speakers to 
participate in external meetings, conferences, and workshops. To 
facilitate the processing of these requests and direct them 
appropriately to determine participation, we have developed web-based 
templates and questionnaires, and have established dedicated points of 
contact throughout the Agency. We have therefore revised the estimated 
burden for the information collection as follows:

[[Page 38058]]



                                 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
----------------------------------------------------------------------------------------------------------------
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 ANDAs certain
 NDAs,\2\ or certain BLAs \3\.
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
External requests for FDA                3,900               1           3,900  0.17 (10                     663
 speakers.                                                                       minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............           4,215  ................           6,360
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ New drug applications.
\3\ Biologics 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.
    We have also added 3,900 responses and 663 hours, annually, to 
reflect burden we believe is associated with requests to FDA for 
speaker participation at an external Agency event, assuming an average 
burden of 10 minutes for each request. As a result of these 
adjustments, the information collection reflects an annual increase in 
responses of 3,119 and an annual decrease in hours of 3,360.

    Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12523 Filed 6-9-23; 8:45 am]
BILLING CODE 4164-01-P


