Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice for Manufacturing, Processing, Packing, and Holding of Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients, 12466-12468 [2021-04380]
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
Approval Under OMB Delegated
Authority of the Temporary Revision of
the Following Information Collection
Report title: Reporting and Disclosure
Requirements Associated with
Emergency Lending Under Section
13(3).
Agency form number: FR A.
OMB control number: 7100–0373.
Frequency: Event-generated.
Respondents: Entities or persons
borrowing under an emergency lending
program or facility established pursuant
to section 13(3) of the Federal Reserve
Act.
Estimated number of respondents: FR
A–1: 4,914; FR A–2: 3,073; FR A–3:
12,150; FR A–4: 5.
Estimated average hours per response:
FR A–1: 8; FR A–2: 40; FR A–3, Lender
per-loan certifications: 2; FR A–3,
Borrower certifications: 8; FR A–4: 1.
Estimated annual burden hours:
257,305.
General description of report: The
Board’s Regulation A (12 CFR part 201)
establishes policies and procedures with
respect to emergency lending under
section 13(3) of the Federal Reserve Act,
as required by sections 1101 and 1103
of the Dodd-Frank Wall Street Reform
and Consumer Protection Act.
Regulation A requires that borrowers
make two certifications in order to
participate in any emergency lending
authorized under section 13(3). These
certifications, designated in this
information collection as FR A–1,
include that the borrowers are not
insolvent and that they cannot obtain
adequate credit accommodation.
In addition to these certifications, the
Board may establish additional
certification requirements for an
individual emergency lending facility.
The second part of the FR A information
collection, the FR A–2, pertains to
reporting requirements associated with
individual facilities that are related to
requirements of the Coronavirus Aid,
Relief, and Economic Security Act
(CARES Act). The third part of FR A,
designated as the FR A–3, pertains to
reporting requirements specific to the
Main Street Expanded Loan Facility, the
Main Street New Loan Facility, the
Main Street Priority Loan Facility, the
Nonprofit Organization Expanded Loan
Facility, and the Nonprofit Organization
New Loan Facility (collectively, the
‘‘Main Street Lending Program’’). The
fourth part of FR A, designated as the
FR A–4, pertains to a disclosure
requirement for Paycheck Protection
Program (PPP) borrowers seeking to
reduce the calculation of existing
outstanding and undrawn available debt
to participate in the Main Street
Lending Program.
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Legal authorization and
confidentiality: The FR A is authorized
pursuant to section 13(3) of the Federal
Reserve Act, which sets out
requirements for emergency lending.
The obligation to respond is required to
obtain a benefit.
The information collected under the
FR A may be kept confidential under
exemption 4 of the Freedom of
Information Act, which protects
commercial or financial information
obtained from a person that is privileged
or confidential.
Current actions: The Board is revising
the FR A information collection to
address information collection
requirements related to borrowers under
the Main Street Lending Program, who
participate in the PPP. Participating
borrowers seeking to reduce the
calculation of ‘‘existing outstanding and
undrawn available debt’’ for purposes of
determining the maximum allowable
loan amount under the Main Street
Lending Program must provide its
eligible lender either with the Small
Business Administration form it has
already completed and submitted to its
PPP lender (which may be the same
lender), or must complete and submit a
Board form to its Main Street lender
during the Main Street loan
underwriting process, as applicable. The
FR A respondent counts for all parts of
the information collection are being
revised to reflect updated estimates of
lender participation in the Main Street
Lending Program.
Detailed Discussion of Public
Comments: On March 2, 2020, the Board
published a notice in the Federal
Register (85 FR 12295) requesting
public comment for 60 days on the
extension, without revision, of the FR A.
One comment was received; it did not
address aspects of the information
collection as described in 5 CFR
1320.8(d). On May 15, 2020, following
the temporary approval of a first set of
revisions to the FR A, the Board
published a Federal Register notice (85
FR 29447) requesting public comment
for 60 days on those temporary
revisions. On June 4, 2020, following
the temporary approval of a second set
of revisions to the FR A, the Board
published a Federal Register notice (85
FR 34448) requesting public comment
for 60 days on those temporary
revisions. On August 21, 2020,
following the temporary approval of a
third set of revisions to the FR A, the
Board published a Federal Register
notice (85 FR 51715) requesting public
comment for 60 days on those
temporary revisions. Comments in
response to all of those requests for
comment are expected to be considered,
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along with any comments received in
response to this request for comment.
Board of Governors of the Federal Reserve
System, February 26, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–04362 Filed 3–2–21; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0362]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice for
Manufacturing, Processing, Packing,
and Holding of Finished
Pharmaceuticals, Including Medical
Gases, and Active Pharmaceutical
Ingredients
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 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 the information collection
associated with current good
manufacturing practice (CGMP) for
drugs, finished pharmaceuticals,
including medical gases, and active
pharmaceutical ingredients (APIs).
DATES: Submit either electronic or
written comments on the collection of
information by May 3, 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 May 3, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 3, 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.
SUMMARY:
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
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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 the Docket No. FDA–
2011–N–0362 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Current
Good Manufacturing Practice
Regulations for Manufacturing,
Processing, Packing, and Holding of
Finished Pharmaceuticals, Including
Medical Gases, and Active
Pharmaceutical Ingredients.’’ 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
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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
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
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12467
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.
Current Good Manufacturing Practice
for Finished Pharmaceuticals, Including
Medical Gases, and Active
Pharmaceutical Ingredients—21 CFR
parts 210 and 211 and 21 U.S.C
351(a)(2)(B).
OMB Control Number 0910–0139—
Extension
This information collection supports
FDA regulations that govern the
manufacture, processing, packing, or
holding of finished pharmaceuticals,
including medical gases, and APIs.
Under section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C 351(a)(2)(B)), a
drug is adulterated if the methods used
in, or the facilities or controls used for
its manufacture, processing, packing, or
holding do not conform to or are not
operated or administered in conformity
with CGMP regulations. FDA is
responsible for enforcing the FD&C Act
as well as related statutes, including the
Public Health Service Act. Congress
enacted these laws to ensure that
covered products meet applicable
requirements regarding the safety,
identity and strength, and the quality
and purity characteristics they purport
or are represented to possess, and are
labeled with adequate warnings and
instructions for use.
The pharmaceutical or drug qualityrelated regulations appear in several
parts of Title 21 Code of Federal
Regulations (CFR) (Food and Drugs),
including sections in parts 1 through 99,
200 through 299, 300 through 499, 600
through 799, and 800 through 1299. The
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
regulations enable a common
understanding of the regulatory process
by describing requirements to be
followed by drug manufacturers,
applicants, and FDA. Under part 211 (21
CFR part 211; see 21 CFR 211.94(e)(1)),
specific requirements for medical gas
containers and closures are also found
in the regulations. Finally, the
information collection also supports
regulations codified under parts 610 and
680 (21 CFR parts 610 and 680), which
reference certain CGMP regulations in
part 211 (see §§ 610.12(g), 610.13(a)(2),
610.18(d), 680.2(f), and 680.3(f)).
These regulations set forth
information collection requirements that
allow FDA to meet its public health
protection responsibilities. Products
that fail to comply with CGMP
requirements may be rendered
adulterated under section 501(a)(2)(B) of
the FD&C Act. To demonstrate that their
products comply with the requirements
of section 501(a)(2)(B), API
manufacturers must maintain CGMP
records; therefore, we have counted
them among respondents who incur
burden for the information collection. In
the table below, we have included an
additional 1,260 respondents to reflect
API manufacturers not included in our
previous submission for renewal.
To assist respondents with the
information collection requirements for
medical gases, we developed a draft
guidance for industry entitled ‘‘Current
Good Manufacturing Practice for
Medical Gases.’’ This guidance, when
finalized will discuss our
recommendations regarding compliance
with applicable requirements found in
the regulations as they apply to these
products. The guidance is available for
download from our internet site at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/current-goodmanufacturing-practice-medical-gases.
We believe the recommendations, if
followed, will help respondents focus
their information collection activities
most efficiently with regard to
demonstrating regulatory compliance.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN—APIS, FINISHED PHARMACEUTICALS, AND MEDICAL GASES 1 2
Section 501(a)(2)(B) of the FD&C
Act; parts 210 and 211
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeping
Total hours
CGMP API Manufacturers ................
CGMP Finished Pharmaceuticals
Manufacturers (excludes medical
gases).
CGMP Medical Gases Manufacturers.
1,260
3,270
256
299
322,560
977,730
0.82 (49.2 minutes) ..........................
0.64 (38 minutes) .............................
264,499
625,747
2,284
280
639,520
0.62 (37 minutes) .............................
396,502
Total ...........................................
........................
........................
1,939,810
...........................................................
1,286,748
1 There
are no capital or operating and maintenance costs associated with the information collection.
and burden per activity have been averaged and rounded.
2 Records
Our estimated burden for the
information collection reflects an
overall decrease of 29,073 hours and
1,762 records annually for CGMP for
finished pharmaceutical manufacturers,
excluding those manufacturers of
medical gases. Our estimated burden for
the information collection also reflects
an overall decrease of 486 hours and
1,574 records annually for medical gas
manufacturers. Our inclusion of API
manufacturers in this collection
represents an addition of 264,499 hours
and 322,560 records prepared.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
AGENCY:
[FR Doc. 2021–04380 Filed 3–2–21; 8:45 am]
SUMMARY:
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BILLING CODE 4164–01–P
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Food and Drug Administration
[Docket No. FDA–2021–N–0132]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration’s Study of How
Consumers Use Flavors To Make
Inferences About Electronic Nicotine
Delivery System Product Qualities and
Intentions To Use (Phase 2)
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 and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on FDA’s
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Sfmt 4703
investigation of how consumers use
flavors to make inferences about
Electronic Nicotine Delivery System
(ENDS) product qualities and intentions
to use.
DATES: Submit either electronic or
written comments on the collection of
information by May 3, 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 May 3, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 3, 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:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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]]>Agencies
[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12466-12468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04380]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0362]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice for Manufacturing,
Processing, Packing, and Holding of Finished Pharmaceuticals, Including
Medical Gases, and Active Pharmaceutical Ingredients
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 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 the
information collection associated with current good manufacturing
practice (CGMP) for drugs, finished pharmaceuticals, including medical
gases, and active pharmaceutical ingredients (APIs).
DATES: Submit either electronic or written comments on the collection
of information by May 3, 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 May 3, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 3, 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.
[[Page 12467]]
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 the Docket No.
FDA-2011-N-0362 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice Regulations for Manufacturing, Processing, Packing, and
Holding of Finished Pharmaceuticals, Including Medical Gases, and
Active Pharmaceutical Ingredients.'' 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
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 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.
Current Good Manufacturing Practice for Finished Pharmaceuticals,
Including Medical Gases, and Active Pharmaceutical Ingredients--21 CFR
parts 210 and 211 and 21 U.S.C 351(a)(2)(B).
OMB Control Number 0910-0139--Extension
This information collection supports FDA regulations that govern
the manufacture, processing, packing, or holding of finished
pharmaceuticals, including medical gases, and APIs. Under section
501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C 351(a)(2)(B)), a drug is adulterated if the methods used in, or
the facilities or controls used for its manufacture, processing,
packing, or holding do not conform to or are not operated or
administered in conformity with CGMP regulations. FDA is responsible
for enforcing the FD&C Act as well as related statutes, including the
Public Health Service Act. Congress enacted these laws to ensure that
covered products meet applicable requirements regarding the safety,
identity and strength, and the quality and purity characteristics they
purport or are represented to possess, and are labeled with adequate
warnings and instructions for use.
The pharmaceutical or drug quality-related regulations appear in
several parts of Title 21 Code of Federal Regulations (CFR) (Food and
Drugs), including sections in parts 1 through 99, 200 through 299, 300
through 499, 600 through 799, and 800 through 1299. The
[[Page 12468]]
regulations enable a common understanding of the regulatory process by
describing requirements to be followed by drug manufacturers,
applicants, and FDA. Under part 211 (21 CFR part 211; see 21 CFR
211.94(e)(1)), specific requirements for medical gas containers and
closures are also found in the regulations. Finally, the information
collection also supports regulations codified under parts 610 and 680
(21 CFR parts 610 and 680), which reference certain CGMP regulations in
part 211 (see Sec. Sec. 610.12(g), 610.13(a)(2), 610.18(d), 680.2(f),
and 680.3(f)).
These regulations set forth information collection requirements
that allow FDA to meet its public health protection responsibilities.
Products that fail to comply with CGMP requirements may be rendered
adulterated under section 501(a)(2)(B) of the FD&C Act. To demonstrate
that their products comply with the requirements of section
501(a)(2)(B), API manufacturers must maintain CGMP records; therefore,
we have counted them among respondents who incur burden for the
information collection. In the table below, we have included an
additional 1,260 respondents to reflect API manufacturers not included
in our previous submission for renewal.
To assist respondents with the information collection requirements
for medical gases, we developed a draft guidance for industry entitled
``Current Good Manufacturing Practice for Medical Gases.'' This
guidance, when finalized will discuss our recommendations regarding
compliance with applicable requirements found in the regulations as
they apply to these products. The guidance is available for download
from our internet site at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-medical-gases. We believe the recommendations, if followed, will help
respondents focus their information collection activities most
efficiently with regard to demonstrating regulatory compliance.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Recordkeeping Burden--APIs, Finished Pharmaceuticals, and Medical Gases 1 2
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Section 501(a)(2)(B) of the Number of records per Total annual per Total hours
FD&C Act; parts 210 and 211 recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
CGMP API Manufacturers........ 1,260 256 322,560 0.82 (49.2 264,499
minutes).
CGMP Finished Pharmaceuticals 3,270 299 977,730 0.64 (38 625,747
Manufacturers (excludes minutes).
medical gases).
CGMP Medical Gases 2,284 280 639,520 0.62 (37 396,502
Manufacturers. minutes).
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Total..................... .............. .............. 1,939,810 ................ 1,286,748
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
\2\ Records and burden per activity have been averaged and rounded.
Our estimated burden for the information collection reflects an
overall decrease of 29,073 hours and 1,762 records annually for CGMP
for finished pharmaceutical manufacturers, excluding those
manufacturers of medical gases. Our estimated burden for the
information collection also reflects an overall decrease of 486 hours
and 1,574 records annually for medical gas manufacturers. Our inclusion
of API manufacturers in this collection represents an addition of
264,499 hours and 322,560 records prepared.
Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04380 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P
