Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quality System Regulation, 76199-76200 [2022-27023]
Download as PDF
<![CDATA[
76199
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
time required for this collection of
information is 25 hours. Based on a
review of the information collection and
the number of notifications received
since 2018, we have made no
adjustments to our burden estimate.
by using the search function. The OMB
control number for this information
collection is 0910–0073. Also include
the FDA docket number found in
brackets in the heading of this
document.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
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.
[FR Doc. 2022–27011 Filed 12–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
Medical Devices: Current Good
Manufacturing Practice Quality System
Regulation—21 CFR part 820
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Quality System
Regulation
AGENCY:
OMB Control Number 0910–0073—
Extension
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 January 12,
2023.
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
SUMMARY:
As authorized under section 520(f) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360j(f)), the
Secretary of the Department of Health
and Human Services has issued
regulations requiring that the methods
used in, and the facilities and controls
used for, the manufacture,
preproduction design validation
(including a process to assess the
performance of a device, but not
including an evaluation of the safety
and effectiveness of a device), packing,
storage, and installation of a device
conform to current good manufacturing
practice (CGMP) and assure that the
device will be safe and effective and
otherwise in compliance with the FD&C
Act.
The quality system regulation (QSR)
under part 820 (21 CFR part 820) sets
forth CGMP requirements governing the
design, manufacture, packing, labeling,
storage, installation, and servicing of all
finished medical devices intended for
human use. The requirements cover
purchasing and service controls, clarify
recordkeeping for device failure and
complaint investigations, clarify
requirements for verifying/validating
production processes and process or
product changes, and clarify
requirements for product acceptance
activities, quality data evaluations, and
corrections of nonconforming product/
quality problems. In the Federal
Register of February 23, 2022 (87 FR
10119), we proposed to incorporate by
reference International Organization for
Standardization 13485 (ISO 13485):
Medical devices—Quality Management
Systems—Requirements for Regulatory
Purposes, the 2016 edition, to the QSR
(RIN 0910–AH99), to align
implementation of requirements.
Information collection under the QSR
is intended to assist FDA in assuring the
safety of medical devices. Requirements
include documenting the establishment
of procedures and identifying required
records that assist FDA in determining
whether firms are in compliance with
CGMP. In particular, for example,
compliance with CGMP design control
requirements should decrease the
number of design-related device failures
that have resulted in deaths and serious
injuries. Records must be made
available for review or copying during
FDA inspection. The regulations in part
820 apply to approximately 29,424
respondents, based on current data
within our device registration and
listing database.
In the Federal Register of August 22,
2022 (87 FR 51433), we published a 60day notice soliciting comment on the
proposed collection of information. No
comments were received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
lotter on DSK11XQN23PROD with NOTICES1
21 CFR part 820;
required records
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Quality System Requirements—Subpart B .......................................................
Design Controls—Subpart C .............................................................................
Document Controls—Subpart D .......................................................................
Purchasing Controls—Subpart E ......................................................................
Identification and Traceability—Subpart F ........................................................
Production and Process Controls—Subpart G .................................................
Acceptance Activities—Subpart H ....................................................................
Nonconforming Product; Corrective and Preventative Action—Subparts I And
J .....................................................................................................................
Labeling and Packaging Controls—Subpart K .................................................
Handling, Storage, Distribution, and Installation—Subpart L ...........................
Records—Subpart M .........................................................................................
Servicing—Subpart N ........................................................................................
Statistical Techniques—section 820.250—Subpart O ......................................
29,424
29,424
29,424
29,424
29,424
29,424
29,424
1
1
1
1
1
1
1
29,424
29,424
29,424
29,424
29,424
29,424
29,424
83
132
11
28
2
31
6
2,442,192
3,883,968
323,664
823,872
58,848
912,144
176,544
29,424
29,424
29,424
29,424
29,424
29,424
1
1
1
1
1
1
29,424
29,424
29,424
29,424
29,424
29,424
23
3
15
10
3
1
676,752
88,272
441,360
294,240
88,272
29,424
Total ...........................................................................................................
..........................
..........................
........................
........................
10,239,552
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
E:\FR\FM\13DEN1.SGM
13DEN1
76200
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
Our estimated burden for the
information collection reflects an
overall increase of 1,217,800 hours. We
made this adjustment to correspond
with an observed increase in
submissions relating to medical devices
and an increase in respondents in the
medical device industry since last OMB
review and approval of the information
collection.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27023 Filed 12–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1794]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Drug
Labeling Provisions and Over-theCounter Monograph Drug User Fee
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 January 12,
2023.
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 0910–0340. Also include
the FDA docket number found in
brackets in the heading of this
document.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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.
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
General Drug Labeling Provisions and
OTC Monograph Drug User Fee
Submissions—21 CFR Part 201
OMB Control Number 0910–0340—
Revision
I. Over-the-Counter (OTC) Drug Product
Labeling
This information collection supports
implementation of general drug labeling
provisions, including certain OTC drug
product labeling requirements found in
FDA regulations in 21 CFR part 201 and
in section 502(x) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 352(x)), as well as OTC drug
product labeling recommendations
discussed in FDA guidance documents
enumerated below. The requirements
and recommendations contained in this
authority help ensure that OTC drug
product labeling includes information to
assist consumers with product selection
and with the safe and effective use of
products that protect the public health
from potential harm that could result
from the dissemination of false and
misleading statements regarding FDAregulated products. As described further
below, the information collection
provisions of one guidance also apply to
prescription drug labeling.
A. Principal Display Panel Labeling
Certain information collection
provisions address the labeling (thirdparty disclosures) that drug companies
provide on the principal display panel
of every OTC drug product in package
form—the part of that drug product’s
label that is most likely to be displayed
or examined in a retail sale setting (see
21 CFR 201.60). Information on this
panel supports consumers’ product
selection, as well as identification after
purchase. OTC drug product companies
must include a declaration of the net
quantity of the OTC product contents on
the principal display panel (see § 201.62
(21 CFR 201.62)). They also must
include a statement of identity (see
§ 201.61 (21 CFR 201.61)).
FDA has made available a draft
guidance for industry entitled
‘‘Statement of Identity and Strength—
Content and Format of Labeling for
Human Nonprescription Drug
Products’’ 1 (available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
1 When final, this guidance will represent FDA’s
current thinking on this topic.
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
quantitative-labeling-sodiumpotassium-and-phosphorus-humanover-counter-and-prescription-drug) that
further addresses content and format of
statement of identity information and
drug product strength information to be
included in the principal display panel
labeling of human nonprescription drug
products. The guidance provides
recommendations to help manufacturers
comply with statement of identity
labeling requirements under § 201.61
and also provides a recommended
alternative to the statement required by
that regulation to provide consumers
with consistent information about the
active ingredients, strength, and dosage
form of the product. Consistent
information about the active
ingredients, strength, and dosage form
of the product on the principal display
panel may aid consumers in comparing
nonprescription drug products and
assist consumers in appropriate selfselection of these products and in
subsequent identification of the
products after purchase.
In estimating burden for statement of
identity labeling, we have excluded the
burden for disclosing any statement of
identity specified in a final OTC
monograph order under section 505G of
the FD&C Act (21 U.S.C. 355h), because
FDA regulations state that for purposes
of § 201.61, the statement of identity
shall be the term or phrase used in an
applicable OTC monograph (see 21 CFR
330.1(c)(1)). By operation of law, OTC
monographs are now established by
order under section 505G of the FD&C
Act, and information collections made
under section 505G are exempt from the
PRA under section 505G(o) of the FD&C
Act.
B. OTC Drug and Prescription Drug
Facts Labeling
In addition to labeling that drug
companies provide on the principal
display panel, companies must also
comply with Agency regulations in
§ 201.66 (21 CFR 201.66), which
requires standard content elements and
formatting for the ‘‘Drug Facts’’ labeling
(DFL) of all OTC drug products. This
standardized labeling helps consumers
understand the information that appears
on OTC drug products to help ensure
that consumers can use those products
safely and effectively. The use of
consistent language in labeling headings
and subheadings helps consumers
comprehend information, and
consistent formatting helps consumers
more efficiently locate information.
The DFL is where OTC drug product
labeling presents certain specific,
standardized content required or
recommended under other regulations
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76199-76200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27023]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2544]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Quality System
Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 January 12, 2023.
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 0910-0073. 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,
[email protected].
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.
Medical Devices: Current Good Manufacturing Practice Quality System
Regulation--21 CFR part 820
OMB Control Number 0910-0073--Extension
As authorized under section 520(f) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the
Department of Health and Human Services has issued regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, preproduction design validation (including a
process to assess the performance of a device, but not including an
evaluation of the safety and effectiveness of a device), packing,
storage, and installation of a device conform to current good
manufacturing practice (CGMP) and assure that the device will be safe
and effective and otherwise in compliance with the FD&C Act.
The quality system regulation (QSR) under part 820 (21 CFR part
820) sets forth CGMP requirements governing the design, manufacture,
packing, labeling, storage, installation, and servicing of all finished
medical devices intended for human use. The requirements cover
purchasing and service controls, clarify recordkeeping for device
failure and complaint investigations, clarify requirements for
verifying/validating production processes and process or product
changes, and clarify requirements for product acceptance activities,
quality data evaluations, and corrections of nonconforming product/
quality problems. In the Federal Register of February 23, 2022 (87 FR
10119), we proposed to incorporate by reference International
Organization for Standardization 13485 (ISO 13485): Medical devices--
Quality Management Systems--Requirements for Regulatory Purposes, the
2016 edition, to the QSR (RIN 0910-AH99), to align implementation of
requirements.
Information collection under the QSR is intended to assist FDA in
assuring the safety of medical devices. Requirements include
documenting the establishment of procedures and identifying required
records that assist FDA in determining whether firms are in compliance
with CGMP. In particular, for example, compliance with CGMP design
control requirements should decrease the number of design-related
device failures that have resulted in deaths and serious injuries.
Records must be made available for review or copying during FDA
inspection. The regulations in part 820 apply to approximately 29,424
respondents, based on current data within our device registration and
listing database.
In the Federal Register of August 22, 2022 (87 FR 51433), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part 820; required Number of records per Total annual per Total hours
records recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Quality System Requirements-- 29,424 1 29,424 83 2,442,192
Subpart B....................
Design Controls--Subpart C.... 29,424 1 29,424 132 3,883,968
Document Controls--Subpart D.. 29,424 1 29,424 11 323,664
Purchasing Controls--Subpart E 29,424 1 29,424 28 823,872
Identification and 29,424 1 29,424 2 58,848
Traceability--Subpart F......
Production and Process 29,424 1 29,424 31 912,144
Controls--Subpart G..........
Acceptance Activities--Subpart 29,424 1 29,424 6 176,544
H............................
Nonconforming Product; 29,424 1 29,424 23 676,752
Corrective and Preventative
Action--Subparts I And J.....
Labeling and Packaging 29,424 1 29,424 3 88,272
Controls--Subpart K..........
Handling, Storage, 29,424 1 29,424 15 441,360
Distribution, and
Installation--Subpart L......
Records--Subpart M............ 29,424 1 29,424 10 294,240
Servicing--Subpart N.......... 29,424 1 29,424 3 88,272
Statistical Techniques-- 29,424 1 29,424 1 29,424
section 820.250--Subpart O...
---------------------------------------------------------------------------------
Total..................... ............... ............... .............. .............. 10,239,552
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 76200]]
Our estimated burden for the information collection reflects an
overall increase of 1,217,800 hours. We made this adjustment to
correspond with an observed increase in submissions relating to medical
devices and an increase in respondents in the medical device industry
since last OMB review and approval of the information collection.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27023 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P
