Notice2021-12214
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients
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
June 10, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 110 (Thursday, June 10, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30960-30961]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12214]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0362]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice for Finished Pharmaceuticals, Including Medical
Gases, and Active Pharmaceutical Ingredients
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 July 12, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0139. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#97c7c5d6c4e3f6f1f1d7f1f3f6b9ffffe4b9f0f8e1"><span class="__cf_email__" data-cfemail="26767467755247404066404247084e4e5508414950">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 active pharmaceutical
ingredients (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 current good
manufacturing practice (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
[[Page 30961]]
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 1,299. The 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-medical-gases">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-medical-gases</a>. We believe the recommendations, if followed, will help
respondents focus their information collection activities most
efficiently with regard to demonstrating regulatory compliance.
In the Federal Register of March 3, 2021 (86 FR 12466), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received requesting
clarification on FDA's basis in calculating its burden estimate. At the
same time, the comment offered no formula or method upon which
alternative figures might be derived. For details regarding all
approved information collections currently in use by FDA, we invite
readers to visit <a href="https://www.reginfo.gov/public/jsp/PRA/praDashboard.myjsp">https://www.reginfo.gov/public/jsp/PRA/praDashboard.myjsp</a>. With regard to this information collection
specifically, our estimate of burden, as defined in 44 U.S.C. 3502(2),
is based on our experience with routine inspections and informal
communications with industry. Additionally, as noted in our 60-day
notice, we account for burden that may be applicable to API and
finished dosage manufacturers along with other respondents to the
information collection. The estimate we provide reflects burden we
attribute to activities associated with recordkeeping requirements
found in applicable regulations, as well as recommendations that may be
found in Agency guidance.\1\ These activities include, among others,
establishing and maintaining standard operating procedures; the need to
consult outside experts; recommendations pertaining to documenting
equipment cleaning and maintenance; and requirements and
recommendations pertaining to master production records, control
records, and distribution records.
---------------------------------------------------------------------------
\1\ See also, ``Q7 Good Manufacturing Practice Guidance for
Active Pharmaceutical Ingredients; Guidance for Industry''
(September 2016).
---------------------------------------------------------------------------
We retain our estimate of the information collection burden, which
is as follows:
Table 1--Estimated Annual Recordkeeping Burden--APIs, Finished Pharmaceuticals, and Medical Gases 1 2
----------------------------------------------------------------------------------------------------------------
Number of
Section 501(a)(2)(B) of the Number of records per Total annual Average burden Total hours
FD&C Act; Parts 210 and 211 recordkeepers recordkeeper records per 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 minutes) 625,747
Manufacturers (excludes
medical gases)..............
CGMP Medical Gases 2,284 280 639,520 0.62 (37 minutes) 396,502
Manufacturers...............
----------------------------------------------------------------------------------
Total.................... .............. .............. 1,939,810 ................. 1,286,748
----------------------------------------------------------------------------------------------------------------
\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: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12214 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 10, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.