Notice2021-19218
Agency Information Collection Activities; Proposed Collection; 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
September 7, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with labeling requirements for prescription drugs.
Full Text
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<title>Federal Register, Volume 86 Issue 170 (Tuesday, September 7, 2021)</title>
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[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50134-50136]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19218]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0918]
Agency Information Collection Activities; Proposed Collection;
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 an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with labeling requirements for prescription drugs.
DATES: Submit either electronic or written comments on the collection
of information by November 8, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 8, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 8, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
[[Page 50135]]
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include Docket No. FDA-
2021-N-0918 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Labeling Requirements for Prescription
Drugs and Biological Products.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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#36666477654257505076505257185e5e4518515940"><span class="__cf_email__" data-cfemail="e2b2b0a3b196838484a2848683cc8a8a91cc858d94">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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.
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 per response Total hours
respondents respondent responses
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Labeling requirements for prescription drugs; 414 1.326 549 3,349................................... 1,838,601
Sec. Sec. 201.56 and 201.57.
Labeling of medical gas containers; Sec. 260 1,663 432,380 0.17 (10 minutes)....................... 43,238
201.328.
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Total..................................... .............. .............. 432,929 ........................................ 1,881,839
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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: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19218 Filed 9-3-21; 8:45 am]
BILLING CODE 4164-01-P
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