[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30960-30961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
PRAStaff@fda.hhs.gov.

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 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.
    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 https://www.reginfo.gov/public/jsp/PRA/praDashboard.myjsp. 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


