Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs, 76853-76855 [2024-21436]
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Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
response are based on past FDA
experience with the various cover sheet
submissions and range from 5 to 30
minutes. The hours per response are
based on the average of these estimates
(18 minutes). The total hours are
rounded to the nearest whole number.
lotter on DSK11XQN23PROD with NOTICES1
Inspection by Accredited Persons
Program Under Section 704 of the FD&C
Act
Section 704(g) of the FD&C Act
provides for accreditation of persons for
the purpose of conducting inspections
and provides the minimum
requirements a person must meet to be
accredited to conduct inspections (an
Accredited Person (AP)). The burden
estimate for requests for accreditation is
based on the number of applications
we’ve received. Once an organization is
accredited, it will not be required to
reapply.
The AP Program permits eligible
manufacturers to use APs to perform
certain inspections. While all firms
remain subject to inspection by FDA,
eligible manufacturers have the option
of requesting inspection by an AP. A
device establishment is eligible for
inspection by APs if the establishment
meets certain conditions of section
704(g)(6) of the FD&C Act, including
that they provide notice of their
intention to use an AP to conduct
inspections of the establishment.
We estimate there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP program. Based
on informal communications with
industry, approximately 10 of these
manufacturers may submit a request to
use an AP in any given year.
Request for Information Under Section
513(g) of the FD&C Act
Respondents may elect to prepare
their 513(g) request for information
using CDRH’s electronic Submission
Template and Resource (eSTAR)
voluntary guided submission
preparation tool, which was developed
to improve submission consistency and
enhance efficiency in the review
process. The total number of annual
responses is based on the average
number of 513(g) requests received each
year by CDRH and CBER respectively.
Based on a review of the information
collection since our last request for
OMB approval, we have made
modifications to our burden estimate. In
our March 2023 change request
submission, we erroneously excluded
the information collection entitled,
‘‘Notification of the intent to use an
Accredited Person.’’ We have included
the information collection activity to
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16:59 Sep 18, 2024
Jkt 262001
this renewal. The information
collection, therefore, reflects a
cumulative increase in burden by 10
annual responses and 150 burden hours.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21435 Filed 9–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4167]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Labeling
Requirements for Prescription Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 revision 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: Either electronic or written
comments on the collection of
information must be submitted by
November 18, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 18, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
PO 00000
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76853
www.regulations.gov 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 https://www.regulations.gov.
• 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:
• 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.
• 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–2024–N–
4167 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Labeling
Requirements for Prescription Drugs.’’
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
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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
E:\FR\FM\19SEN1.SGM
19SEN1
lotter on DSK11XQN23PROD with NOTICES1
76854
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. 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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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, PRAStaff@
fda.hhs.gov.
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 revision 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
VerDate Sep<11>2014
16:59 Sep 18, 2024
Jkt 262001
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 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 (§ 201.50 to § 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
§§ 201.56, 201.57, and 201.80. Since last
approval of the information collection,
FDA requested, and OMB approved,
adding tasks provided for under
§ 201.25(d), requiring that
manufacturers submit a written request
for exemption from applicable bar code
requirements, and tasks relating to
exceptions or alternatives to the labeling
requirements of products in the
Strategic National Stockpile (SNS) as
provided for in § 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.
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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,’’ (July 2013). The guidance
document includes instruction on
communicating with FDA regarding
labeling changes required under section
505(o)(4) (Section IV—Procedures) and
is available for download from our
website at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/safety-labelingchanges-implementation-section-505o4federal-food-drug-and-cosmetic-act.
‘‘Guidance for Industry on
Hypertension Indication: Drug Labeling
for Cardiovascular Outcome Claims,’’
(March 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-labelingcardiovascular-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, 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 with regard
to 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.
FDA estimates the burden of this
collection of information as follows:
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76855
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Total annual
responses
Average burden
per response
Total hours
Labeling requirements for prescription drugs;
§§ 201.56 and 201.57.
Labeling applicable to medical gas containers;
§§ 201.161(b) and 201.328.
Exemption from barcode requirements § 201.25(d) .....
Safety labeling required under section 505(o)(4) of
the Federal Food, Drug, and Cosmetic Act (FD&C
Act), and rebuttal statement.
Safety labeling changes; posting approved letter on
application holder’s website.
Exceptions or alternatives to labeling requirements for
human drug product held by SNS; § 201.26.
Hypertension claims; recommended labeling considerations.
414
1.326
549
3,349 .....................
1,838,601
260
1,663
432,380
0.17 (10 minutes) ..
73,505
2
36
1
1
2
36
24 ..........................
6 ............................
48
216
351
1
351
4 ............................
1,404
1
1
1
32 ..........................
32
5
1
5
18 ..........................
90
Total ......................................................................
........................
........................
433,324
...............................
1,913,896
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 § 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
§ 201.161(b), established by a final rule
published 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 § 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
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR section
associated with safety labeling
requirements established in
section505(o)(4) of the FD&C Act.
Similarly, we retain the currently
approved estimate for exceptions to
labeling under § 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 drug
products that include a hypertension
indication as discussed in the
applicable guidance, reducing the
overall estimate for this element by 4
hours annually.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21436 Filed 9–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Funding,
Poison Control Centers Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice of supplemental award.
HRSA is awarding
supplemental funds in fiscal year 2024
to provide coverage for calls to the tollfree Poison Help line that originate from
Puerto Rico. The current program period
of performance ends on August 31,
2024.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Maureen Perkins, MPH; Team Lead;
Poison Control Program; Division of
Child, Adolescent and Family Health;
Maternal and Child Health Bureau;
HRSA, at mperkins@hrsa.gov and 301–
443–9163.
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award:
New York City Health & Hospitals
Corporation.
Amount of Non-Competitive
Award(s): One award of $265,188.
Project Period: September 1, 2024, to
August 31, 2025.
Assistance Listing (CFDA) Number:
93.253.
Award Instrument: Supplement for
Poison Control Services.
Authority: 42 U.S.C. 300d–73 (title
XII, 1273 of the Public Health Service
Act).
TABLE 1—RECIPIENT AND AWARD AMOUNT
Grant No.
Award recipient name
H4BHS15477 ...................................................
New York City Health & Hospitals Corporation ..................................
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16:59 Sep 18, 2024
Jkt 262001
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State
19SEN1
NY
Award amount
$265,188
]]>Agencies
[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76853-76855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21436]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4167]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Labeling Requirements for Prescription Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 revision 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: Either electronic or written comments on the collection of
information must be submitted by November 18, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 18, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
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.
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-
2024-N-4167 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Labeling Requirements for Prescription
Drugs.'' 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
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
[[Page 76854]]
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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,
[email protected].
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 revision 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 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. 201.50 to Sec. 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 bar code 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,'' (July 2013). The guidance
document includes instruction on communicating with FDA regarding
labeling changes required under section 505(o)(4) (Section IV--
Procedures) 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,'' (March 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, 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 with regard to 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 76855]]
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling requirements for prescription drugs; 414 1.326 549 3,349................................... 1,838,601
Sec. Sec. 201.56 and 201.57.
Labeling applicable to medical gas containers; 260 1,663 432,380 0.17 (10 minutes)....................... 73,505
Sec. Sec. 201.161(b) and 201.328.
Exemption from barcode requirements Sec. 2 1 2 24...................................... 48
201.25(d).
Safety labeling required under section 36 1 36 6....................................... 216
505(o)(4) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), and rebuttal
statement.
Safety labeling changes; posting approved 351 1 351 4....................................... 1,404
letter on application holder's website.
Exceptions or alternatives to labeling 1 1 1 32...................................... 32
requirements for human drug product held by
SNS; Sec. 201.26.
Hypertension claims; recommended labeling 5 1 5 18...................................... 90
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 a final
rule published 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
section505(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 drug products that include a
hypertension indication as discussed in the applicable guidance,
reducing the overall estimate for this element by 4 hours annually.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21436 Filed 9-18-24; 8:45 am]
BILLING CODE 4164-01-P
