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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 [www.gpo.gov]
[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 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 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: www.phe.gov/about/sns/Pages/default.aspx.
    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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act.
    ``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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims.
    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\
----------------------------------------------------------------------------------------------------------------
                                               Number of        Total
   Activity/21 CFR section      Number of    responses per      annual      Average burden per      Total hours
                               respondents     respondent     responses          response
----------------------------------------------------------------------------------------------------------------
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.
                             -----------------------------------------------------------------------------------
    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
```