Document ID: FDA-2011-N-0362-0011
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2021-03-03T05:00Z

[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]

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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.

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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 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, 
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 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
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                                                   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
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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