Notice2025-02154
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling Requirements for Prescription Drugs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA 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.
Full Text
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<title>Federal Register, Volume 90 Issue 21 (Monday, February 3, 2025)</title>
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[Federal Register Volume 90, Number 21 (Monday, February 3, 2025)]
[Notices]
[Pages 8801-8802]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02154]
[[Page 8801]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4167]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Labeling Requirements
for Prescription Drugs
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA 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 March 5, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#cd9d9f8c9eb9acabab8daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="8adad8cbd9feebececcaeceeeba4e2e2f9a4ede5fc">[email protected]</span></a>.
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 helps implement statutory and
regulatory requirements that govern the labeling of prescription drugs.
FDA regulations codified in part 201 (21 CFR part 201), subpart B
(Sec. Sec. 201.50 through 201.58), apply to requisite labeling
elements that include a statement of identity; a declaration of net
quantity of contents; a statement of dosage; and specific content and
formatting of information. The regulations also provide for requesting
that FDA waive any requirement under Sec. Sec. 201.56, 201.57, and
201.80. Since last approval of the information collection, FDA
requested, and OMB approved, adding tasks provided for under Sec.
201.25(d), requiring that manufacturers submit a written request for
exemption from applicable barcode requirements, and tasks relating to
exceptions or alternatives to the labeling requirements of products in
the Strategic National Stockpile (SNS) as provided for in Sec. 201.26,
to the scope of the activity. Under the Public Health Service Act (PHS
Act), the Department of Health and Human Services stockpiles medical
products that are essential to the security of the Nation (section
319F-2 of the PHS Act (42 U.S.C. 247d-6b). Information regarding the
SNS is available at the following website: <a href="http://www.phe.gov/about/sns/Pages/default.aspx">www.phe.gov/about/sns/Pages/default.aspx</a>.
Relevant information regarding applicable statutory and regulatory
requirements are also discussed in topic-specific guidance documents
issued consistent with 21 CFR 314.445, 21 CFR 601.29 (guidance
documents), and Agency Good Guidance Practice regulations in 21 CFR
10.115, which provide for public comment at any time. The following
guidance documents discuss activities included in the information
collection:
``Safety Labeling Changes--Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic Act'' (FD&C Act) (78 FR 45930,
July 30, 2013). The guidance document includes instruction on
communicating with FDA regarding labeling changes required under
section 505(o)(4) (Section IV--Procedures) (21 U.S.C. 355(o)(4)) and is
available for download from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act</a>.
``Guidance for Industry on Hypertension Indication: Drug Labeling
for Cardiovascular Outcome Claims'' (76 FR 14024, March 15, 2011). The
guidance document is intended to help respondents with developing
labeling for cardiovascular outcome claims for drugs that are indicated
to treat hypertension. The guidance document is available for download
from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims</a>.
Respondents to the information collection are sponsors of product
labeling subject to the applicable labeling requirements. We
characterize the information collection activities as recordkeeping,
consistent with 5 CFR 1320.3(m), noting that a recordkeeping
requirement means a requirement to maintain specified records,
including the requirement to retain and notify third parties, the
Federal Government, or the public regarding such records. Regulations
in part 201 govern the statement of ingredients and declaration of net
quantity of contents regarding prescription drug product labeling. The
regulations require that firms identify bulk or transport containers
with the name of the product contained therein and that containers be
accompanied by documentation that identifies the product as meeting
applicable compendial standards. 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.
In the Federal Register of September 19, 2024 (89 FR 76853), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, they
were not responsive to the four collection of information topics
solicited.
We estimate the burden of this information collection as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Total
Activity/21 CFR section Number of responses per annual Average burden per Total hours
respondents respondent responses 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.
[[Page 8802]]
Labeling applicable to 260 1,663 432,380 0.17 (10 minutes)..... 73,505
medical gas containers;
Sec. Sec. 201.161(b) and
201.328.
Exemption from barcode 2 1 2 24.................... 48
requirements Sec.
201.25(d).
Safety labeling required 36 1 36 6..................... 216
under section 505(o)(4) of
the FD&C Act, and rebuttal
statement.
Safety labeling changes; 351 1 351 4..................... 1,404
posting approved letter on
application holder's
website.
Exceptions or alternatives 1 1 1 32.................... 32
to labeling requirements
for human drug product held
by SNS; Sec. 201.26.
Hypertension claims; 5 1 5 18.................... 90
recommended labeling
considerations.
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Total................... ............ ............... 433,324 ...................... 1,913,896
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on our evaluation, we have retained the currently approved
estimate that 414 applicants will prepare an average of 549
prescription drug labels annually 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.
New medical gas containers must meet applicable requirements found
in 21 CFR part 211, as well as specific labeling requirements in Sec.
201.328. Consistent with statutory authority under the Consolidated
Appropriations Act, 2017 (Pub. L. 115-31), we have revised the
information collection to include burden associated new medical gas
labeling requirements under Sec. 201.161(b), established by final rule
in the Federal Register of June 18, 2024 (89 FR 51738). We estimate 260
respondents will incur burden for the design, testing, production, and
submission of labeling for new medical gas containers as established in
Sec. 201.328 and assume an average of 10 minutes (0.17) is required
for these activities.
Based on our evaluation, few requests for exemption from barcode
requirements are received, and we have therefore made no changes to the
currently approved estimate for this activity. Likewise, we have also
retained the currently approved estimate for information collection
activities associated with safety labeling requirements established in
section 505(o)(4) of the FD&C Act. Similarly, we retain the currently
approved estimate for exceptions to labeling under Sec. 201.26;
however, this activity was previously approved in OMB control number
0910-0614 and is a new element to the collection, adding 1 response and
32 hours annually.
Finally, we have combined activity elements associated with
labeling recommendations regarding drugs products that include a
hypertension indication as discussed in the applicable March 2011
guidance referenced above, reducing the overall estimate for this
element by 4 hours annually.
Dated: January 28, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-02154 Filed 1-30-25; 11:15 am]
BILLING CODE 4164-01-P
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