[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\
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Number of
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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).
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Total..................... .............. .............. 432,929 ................ 1,912,106
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\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