Document ID: FDA-2021-N-0918-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Labeling
Requirements for Prescription Drugs
Posted Date: 2021-12-10T05:00Z

[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70504-70505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26730]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0918]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Labeling Requirements 
for Prescription Drugs

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 January 10, 2022.

[[Page 70505]]

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 0910-0572. 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.

Labeling Requirements for Prescription Drugs

OMB Control Number 0910-0572--Revision

    This information collection supports FDA regulations governing the 
labeling of prescription drugs. The regulations are codified in 21 CFR 
part 201, subpart B (21 CFR 201.50 through 201.58) and set forth both 
general requirements, as well as specific content and format 
requirements. The regulations also provide for requesting a waiver from 
any labeling requirement and do not apply to biological products that 
are subject to the requirements of section 351 of the Public Health 
Service Act.
    We are revising the information collection to include burden 
associated with regulations applicable to medical gas labeling found in 
Sec.  201.328 (21 CFR 201.328) and established by a final rule in the 
Federal Register of November 18, 2016 (81 FR 81685 at 81694). While we 
included corresponding changes and adjustments resulting from the final 
rule to the information collection approved under OMB control number 
0910-0139 as it pertains to good manufacturing practice requirements 
and regulations in part 211 (21 CFR part 211), we did not make 
corresponding changes and adjustments to this information collection 
with regard to burden that may be associated with labeling requirements 
found in Sec.  201.328 (81 FR 81685 at 81694).
    To assist respondents with the information collection we continue 
to develop and issue guidance documents, available from our searchable 
guidance database at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. All Agency guidance documents are issued 
consistent with our good guidance practice regulations found in 21 CFR 
10.115, which provide for public comment at any time.
    In the Federal Register of September 7, 2021 (86 FR 50134), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
    Activity/21 CFR section        Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
Labeling requirements for                  414           1.326             549  3,349...........       1,838,601
 prescription drugs; Sec.
 Sec.   201.56 and 201.57.
Labeling of medical gas                    260           1,663         432,380  0.17 (10                  73,505
 containers; Sec.   201.328.                                                     minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............         432,929  ................       1,912,106
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    New drug product and biological product applicants must: (1) Design 
and create prescription drug labeling containing ``Highlights,'' 
``Contents,'' and ``Full Prescribing Information''; (2) test the 
designed labeling (for example, to ensure that the designed labeling 
fits into carton-enclosed products); and (3) submit it to FDA for 
approval. Based on our experience with the information collection, we 
estimate 414 applicants will prepare an average of 549 prescription 
drug labels and assume it will require 3,349 hours to design, test, and 
submit to FDA as part of a new drug application or a biologics license 
application. Similarly, new medical gas containers must meet applicable 
requirements found in part 211, as well as specific labeling 
requirements in Sec.  201.328. We estimate that 260 respondents will 
incur burden for the design, testing, production, and submission of 
labeling for new medical gas containers as required under Sec.  201.328 
and assume an average of 10 minutes (0.17) is required for these 
activities.
    Our estimated burden for the information collection reflects an 
overall increase resulting from an increase in submissions for new 
product labeling as well as from the revision to include burden 
associated with requirements in Sec.  201.328.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26730 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P