Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Current Good Manufacturing Practice Quality System Regulation, 46347-46351 [2013-18351]
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Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices
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[FR Doc. 2013–18394 Filed 7–26–13; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0853]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices
Current Good Manufacturing Practice
Quality System Regulation
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2012–N–0961]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Environmental Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Environmental Impact Considerations’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
On
February 25, 2013, the Agency
submitted a proposed collection of
information entitled ‘‘Environmental
Impact Considerations’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0322. The approval expires on
May 31, 2016. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
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46347
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including 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
recordkeeping requirements related to
the medical devices current good
manufacturing practice (CGMP) quality
system (QS) regulation (CGMP/QS
regulation).
DATES: Submit either electronic or
written comments on the collection of
information by September 30, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
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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.
Medical Devices Current Good
Manufacturing Practice Quality System
Regulation—21 CFR Part 820 (OMB
Control Number 0910–0073)—Extension
Under section 520(f) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360j(f)), the
Secretary of the Department of Health
and Human Services has the authority
to prescribe 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 CGMP, as described in such
regulations, to assure that the device
will be safe and effective and otherwise
in compliance with the FD&C Act.
The CGMP/QS regulation
implementing authority provided by
this statutory provision is found under
part 820 (21 CFR part 820) and sets forth
basic CGMP requirements governing the
design, manufacture, packing, labeling,
storage, installation, and servicing of all
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finished medical devices intended for
human use. The authority for this
regulation is covered under sections
501, 502, 510, 513, 514, 515, 518, 519,
520, 522, 701, 704, 801, and 803 of the
FD&C Act (21 U.S.C. 351, 352, 360,
360c, 360d, 360e, 360h, 360i, 360j, 360l,
371, 374, 381, and 383). The CGMP/QS
regulation includes requirements for
purchasing and service controls,
clarifies recordkeeping requirements for
device failure and complaint
investigations, clarifies requirements for
verifying/validating production
processes and process or product
changes, and clarifies requirements for
product acceptance activities quality
data evaluations and corrections of
nonconforming product/quality
problems.
Requirements are compatible with
specifications in the international
standards ‘‘ISO 9001: Quality Systems
Model for Quality Assurance in Design/
Development, Production, Installation,
and Servicing.’’ The CGMP/QS
information collections will assist FDA
inspections of manufacturers for
compliance with QS requirements
encompassing design, production,
installation, and servicing processes.
Section 820.20(a) through (e) requires
management with executive
responsibility to establish, maintain,
and/or review the following topics: (1)
The quality policy, (2) the
organizational structure, (3) the quality
plan, and (4) the quality system
procedures of the organization.
Section 820.22 requires the conduct
and documentation of QS audits and reaudits. Section 820.25(b) requires the
establishment of procedures to identify
training needs and documentation of
such training.
Section 820.30(a)(1) and (b) through
(j) requires, in respective order, the
establishment, maintenance, and/or
documentation of the following topics:
(1) Procedures to control design of class
III and class II devices and certain class
I devices as listed therein; (2) plans for
design and development activities and
updates; (3) procedures identifying,
documenting, and approving design
input requirements; (4) procedures
defining design output, including
acceptance criteria, and documentation
of approved records; (5) procedures for
formal review of design results and
documentation of results in the design
history file (DHF); (6) procedures for
verifying device design and
documentation of results and approvals
in the DHF; (7) procedures for validating
device design, including documentation
of results in the DHF; (8) procedures for
translating device design into
production specifications; (9)
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procedures for documenting, verifying,
and validating approved design changes
before implementation of changes; and
(10) the records and references
constituting the DHF for each type of
device.
Section 820.40 requires manufacturers
to establish and maintain procedures
controlling approval and distribution of
required documents and document
changes.
Section 820.40(a) and (b) requires the
establishment and maintenance of
procedures for the review, approval,
issuance, and documentation of
required records (documents) and
changes to those records.
Section 820.50(a) and (b) requires the
establishment and maintenance of
procedures and requirements to ensure
service and product quality, records of
acceptable suppliers, and purchasing
data describing specified requirements
for products and services.
Sections 820.60 and 820.65 require,
respectively, the establishment and
maintenance of procedures for
identifying all products from receipt to
distribution and for using control
numbers to track surgical implants and
life-sustaining or supporting devices
and their components.
Section 820.70(a) through (e), (g)(1)
through (g)(3), (h), and (i) requires the
establishment, maintenance, and/or
documentation of the following topics:
(1) Process control procedures; (2)
procedures for verifying or validating
changes to specification, method,
process, or procedure; (3) procedures to
control environmental conditions and
inspection result records; (4)
requirements for personnel hygiene; (5)
procedures for preventing
contamination of equipment and
products; (6) equipment adjustment,
cleaning, and maintenance schedules;
(7) equipment inspection records; (8)
equipment tolerance postings,
procedures for utilizing manufacturing
materials expected to have an adverse
effect on product quality; and (9)
validation protocols and validation
records for computer software and
software changes.
Sections 820.72(a), (b)(1), and (b)(2)
and 820.75(a) through (c) require,
respectively, the establishment,
maintenance, and/or documentation of
the following topics: (1) Equipment
calibration and inspection procedures;
(2) national, international, or in-house
calibration standards; (3) records that
identify calibrated equipment and next
calibration dates; (4) validation
procedures and validation results for
processes not verifiable by inspections
and tests; (5) procedures for keeping
validated processes within specified
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limits; (6) records for monitoring and
controlling validated processes; and (7)
records of the results of revalidation
where necessitated by process changes
or deviations.
Sections 820.80(a) through (e) and
820.86, respectively, require the
establishment, maintenance, and/or
documentation of the following topics:
(1) Procedures for incoming acceptance
by inspection, test, or other verification;
(2) procedures for ensuring that in
process products meet specified
requirements and the control of product
until inspection and tests are
completed; (3) procedures for, and
records that show, incoming acceptance
or rejection is conducted by inspections,
tests or other verifications; (4)
procedures for, and records that show,
finished devices meet acceptance
criteria and are not distributed until
device master record (DMR) activities
are completed; (5) records in the device
history record (DHR) showing
acceptance dates, results, and
equipment used; and (6) the acceptance/
rejection identification of products from
receipt to installation and servicing.
Sections 820.90(a), (b)(1), and (b)(2)
and 820.100 require, respectively, the
establishment, maintenance and/or
documentation of the following topics:
(1) Procedures for identifying,
recording, evaluating, and disposing of
nonconforming product; (2) procedures
for reviewing and recording concessions
made for, and disposition of,
nonconforming product; (3) procedures
for reworking products, evaluating
possible adverse rework effect and
recording results in the DHR; (4)
procedures and requirements for
corrective and preventive actions,
including analysis, investigation,
identification and review of data,
records, causes, and results; and (5)
records for all corrective and preventive
action activities.
Section 820.100(a)(1) through (a)(7)
states that procedures and requirements
shall be established and maintained for
corrective/preventive actions, including
the following: (1) Analysis of data from
process, work, quality, servicing
records, investigation of
nonconformance causes; (2)
identification of corrections and their
effectiveness; (3) recording of changes
made; and (4) appropriate distribution
and managerial review of corrective and
preventive action information. Section
820.120 states that manufacturers shall
establish/maintain procedures to control
labeling storage/application; and
examination/release for storage and use,
and document those procedures.
Sections 820.120(b) and (d), 820.130,
820.140, 820.150(a) and (b), 820.160(a)
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and (b), and 820.170(a) and (b),
respectively, require the establishment,
maintenance, and/or documentation of
following topics: (1) Procedures for
controlling and recording the storage,
examination, release, and use of
labeling; (2) the filing of labels/labeling
used in the DHR; (3) procedures for
controlling product storage areas and
receipt/dispatch authorizations; (4)
procedures controlling the release of
products for distribution; (5)
distribution records that identify
consignee, product, date, and control
numbers; and (6) instructions,
inspection and test procedures that are
made available, and the recording of
results for devices requiring installation.
Sections 820.180(b) and (c),
820.181(a) through (e), 820.184(a)
through (f), and 820.186 require,
respectively, the maintenance of records
that are: (1) Retained at prescribed
site(s), made readily available and
accessible to FDA and retained for the
device’s life expectancy or for 2 years;
(2) contained or referenced in a DMR
consisting of device, process, quality
assurance, packaging and labeling, and
installation, maintenance, and servicing
specifications and procedures; (3)
contained in a DHR and demonstrate the
manufacture of each unit, lot, or batch
of product in conformance with DMR
and regulatory requirements, include
manufacturing and distribution dates,
quantities, acceptance documents,
labels and labeling, control numbers;
and (4) contained in a quality system
record, consisting of references,
documents, procedures, and activities
not specific to particular devices.
Sections 820.198(a) through (c) and
820.200(a) through (d), respectively,
require the establishment, maintenance,
and/or documentation of the following
topics: (1) Complaint files and
procedures for receiving, reviewing and
evaluating complaints; (2) complaint
investigation records identifying the
device, complainant, and relationship of
the device to the incident; (3) complaint
records that are reasonably accessible to
the manufacturing site or at prescribed
sites; (4) procedures for performing and
verifying that device servicing
requirements are met and that service
reports involving complaints are
processed as complaints; and (5) service
reports that record the device, service
activity, and test and inspection data.
Section 820.250 requires the
establishment and maintenance of
procedures to identify valid statistical
techniques necessary to verify process
and product acceptability; and sampling
plans, when used, which are written
and based on valid statistical rationale;
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46349
and procedures for ensuring adequate
sampling methods.
The CGMP/QS regulation added
design and purchasing controls,
modified previous critical device
requirements, revised previous
validation and other requirements, and
harmonized device CGMP requirements
with QS specifications in the
international standard ‘‘ISO 9001:
Quality Systems Model for Quality
Assurance in Design/Development,
Production, Installation, and Servicing.’’
The rule does not apply to
manufacturers of components or parts of
finished devices, or to manufacturers of
human blood and blood components
subject to 21 CFR part 606. With respect
to devices classified in class I, design
control requirements apply only to class
I devices listed in § 820.30(a)(2) of the
regulation. The rule imposes burden
upon: (1) Finished device manufacturer
firms, which are subject to all
recordkeeping requirements; (2)
finished device contract manufacturers,
specification developers; and (3)
repacker, relabelers, and contract
sterilizer firms, which are subject only
to requirements applicable to their
activities. In addition, remanufacturers
of hospital single-use devices (SUDs) are
now to be considered to have the same
requirements as manufacturers in regard
to the regulation. The establishment,
maintenance and/or documentation of
procedures, records, and data required
by the regulation assists FDA in
determining whether firms are in
compliance with CGMP requirements,
which are intended to ensure that
devices meet their design, production,
labeling, installation, and servicing
specifications and, thus are safe,
effective, and suitable for their intended
purpose. In particular, compliance with
CGMP design control requirements
should decrease the number of designrelated device failures that have resulted
in deaths and serious injuries.
The CGMP/QS regulation applies to
approximately 25,986 respondents. A
query of the Agency’s registration and
listing database shows that
approximately 15,113 domestic and
10,873 foreign establishments are
respondents to this information
collection.1 These recordkeepers consist
of manufacturers, subject to all
requirements and contract
manufacturers, specification developers,
repackers, relabelers, and contract
sterilizers, subject only to requirements
applicable to their activities. Hospital
remanufacturers of SUDs are now
defined to be manufacturers under
guidance issued by FDA’s Center for
1 Based
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Devices and Radiological Health, Office
of Surveillance and Biometrics.
Respondents to this collection have no
reporting activities, but must make
required records available for review or
copying during FDA inspection. Except
for manufacturers, not every type of firm
is subject to every CGMP/QS
requirement. For example, all are
subject to Quality Policy (§ 820.20(a)),
Document Control (§ 820.40), and other
requirements, whereas only
manufacturers and specification
developers are subject to subpart C,
Design Controls. The PRA burden
placed on the 25,986 establishments is
an average burden.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
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Activity/21 CFR Section
Quality policy—820.20(a) .....
Organization—820.20(b) ......
Management review—
820.20(c) ..........................
Quality planning—820.20(d)
Quality system procedures—
820.20(e) ..........................
Quality audit—820.22 ..........
Training—820.25(b) .............
Design procedures—
820.30(a)(1) ......................
Design and development
planning—820.30(b) .........
Design input—820.30(c) ......
Design output—820.30(d) ....
Design review—820.30(e) ...
Design verification—
820.30(f) ...........................
Design validation—820.30(g)
Design transfer—820.30(h) ..
Design changes—820.30(i)
Design history file—820.30(j)
Document controls—820.40
Documentation approval and
distribution and document
changes—820.40(a) and
(b) .....................................
Purchasing controls—
820.50(a) ..........................
Purchasing data—820.50(b)
Identification—820.60 ..........
Traceability—820.65 ............
Production and process controls—820.70(a) ................
Production and process
changes and environmental control—820.70(b)
and (c) ..............................
Personnel—820.70(d) ..........
Contamination control—
820.70(e) ..........................
Equipment maintenance
schedule, inspection, and
adjustment—820.70(g)(1)
to (g)(3) .............................
Manufacturing material—
820.70(h) ..........................
Automated processes—
820.70(i) ...........................
Control of inspection, measuring, and test equipment—820.72(a) ...............
Calibration procedures,
standards, and records—
820.72(b)(1) to (b)(2) ........
Process validation—
820.75(a) ..........................
Validated process parameters, monitoring, control
methods, and data—
820.75(b) ..........................
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Number of
records per
recordkeeper
Number of
recordkeepers
Total annual records
Average
burden per
recordkeeping
Total hours
25,986
25,986
25,986
25,986
7
4
181,902
103,944
25,986
25,986
1
1
25,986
25,986
6
10
155,916
259,860
25,986
25,986
25,986
1
1
1
25,986
25,986
25,986
10
33
13
259,860
857,538
337,818
25,986
1
25,986
2
51,972
25,986
25,986
25,986
25,986
1
1
1
1
25,986
25,986
25,986
25,986
6
2
2
23
155,916
51,972
51,972
597,678
25,986
25,986
25,986
25,986
25,986
25,986
1
1
1
1
1
1
25,986
25,986
25,986
25,986
25,986
25,986
37
37
3
17
3
9
961,482
961,482
77,958
441,762
77,958
233,874
25,986
1
25,986
2
51,972
25,986
25,986
25,986
25,986
1
1
1
1
25,986
25,986
25,986
25,986
22
6
1
1
571,692
155,916
25,986
25,986
25,986
1
25,986
2
51,972
25,986
25,986
1
1
25,986
25,986
2
3
51,972
77,958
25,986
1
25,986
2
51,972
25,986
1
25,986
1
25,986
25,986
1
25,986
2
51,972
25,986
1
25,986
8
207,888
25,986
1
25,986
5
129,930
25,986
1
25,986
1
25,986
25,986
1
25,986
3
77,958
25,986
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1
1
1
25,986
1
25,986
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46351
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Revalidation—820.75(c) .......
Acceptance activities—
820.80(a) to (e) ................
Acceptance status—820.86
Control of nonconforming
product—820.90(a) ...........
Nonconforming product review/disposition procedures and rework procedures—820.90(b)(1) to
(b)(2) .................................
Procedures for corrective/
preventive actions—
820.100(a)(1) to (a)(7) ......
Corrective/preventive activities—820.100(b) ...............
Labeling procedures—
820.120(b) ........................
Labeling documentation—
820.120(d) ........................
Device packaging—820.130
Handling—820.140 ..............
Storage—820.150(a) and (b)
Distribution procedures and
records—820.160(a) and
(b) .....................................
Installation—820.170 ...........
Record retention period—
820.180(b) and (c) ............
Device master record—
820.181 ............................
Device history record—
820.184 ............................
Quality system record—
820.186 ............................
Complaint files—820.198(a),
(c), and (g) ........................
Servicing procedures and reports—820.200(a) and (d)
Statistical techniques procedures and sampling
plans—820.250 ................
Total ..............................
1 There
Average
burden per
recordkeeping
Total hours
1
25,986
1
25,986
25,986
25,986
1
1
25,986
25,986
5
1
129,930
25,986
25,986
1
25,986
5
129,930
25,986
1
25,986
5
129,930
25,986
1
25,986
12
311,832
25,986
1
25,986
1
25,986
25,986
1
25,986
1
25,986
25,986
25,986
25,986
25,986
1
1
1
1
25,986
25,986
25,986
25,986
1
1
6
6
25,986
25,986
155,916
155,916
25,986
25,986
1
1
25,986
25,986
1
2
25,986
51,972
25,986
1
25,986
2
51,972
25,986
1
25,986
1
25,986
25,986
1
25,986
1
25,986
25,986
1
25,986
1
25,986
25,986
1
25,986
5
129,930
25,986
1
25,986
3
77,958
25,986
1
25,986
1
25,986
........................................
........................
........................................
........................
9,043,128
are no capital costs or operating and maintenance costs associated with this collection of information.
ACTION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Trial Designs and Endpoints for Liver
Disease Secondary to Nonalcoholic
Steatohepatitis; Public Workshop
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
16:14 Jul 30, 2013
Jkt 229001
Notice of public workshop.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research in
cosponsorship with the American
Association for the Study of Liver
Diseases (AASLD) is announcing a 2day public workshop entitled ‘‘Trial
Designs and Endpoints for Liver Disease
Secondary to Nonalcoholic fatty liver
disease (NAFLD).’’ There are no
approved treatments for NAFLD and its
complications of nonalcoholic
steatohepatitis (NASH) and liver fibrosis
and cirrhosis. This workshop will
provide a forum to discuss trial design,
including endpoints for clinical trials in
NAFLD, to promote efficient drug
SUMMARY:
[FR Doc. 2013–18351 Filed 7–30–13; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
Total annual records
25,986
Dated: July 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Number of
records per
recordkeeper
Number of
recordkeepers
Activity/21 CFR Section
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
development in this area and thus
improved treatments for patients.
Date and Time: The public workshop
will be held on September 5 and 6,
2013, from 8 a.m. to 5 p.m.
Location: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, in the Great Room
(room 1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46347-46351]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0853]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices Current Good Manufacturing Practice
Quality System Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including 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 recordkeeping requirements
related to the medical devices current good manufacturing practice
(CGMP) quality system (QS) regulation (CGMP/QS regulation).
DATES: Submit either electronic or written comments on the collection
of information by September 30, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of
[[Page 46348]]
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.
Medical Devices Current Good Manufacturing Practice Quality System
Regulation--21 CFR Part 820 (OMB Control Number 0910-0073)--Extension
Under section 520(f) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the Department of
Health and Human Services has the authority to prescribe 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 CGMP, as described in
such regulations, to assure that the device will be safe and effective
and otherwise in compliance with the FD&C Act.
The CGMP/QS regulation implementing authority provided by this
statutory provision is found under part 820 (21 CFR part 820) and sets
forth basic CGMP requirements governing the design, manufacture,
packing, labeling, storage, installation, and servicing of all finished
medical devices intended for human use. The authority for this
regulation is covered under sections 501, 502, 510, 513, 514, 515, 518,
519, 520, 522, 701, 704, 801, and 803 of the FD&C Act (21 U.S.C. 351,
352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and
383). The CGMP/QS regulation includes requirements for purchasing and
service controls, clarifies recordkeeping requirements for device
failure and complaint investigations, clarifies requirements for
verifying/validating production processes and process or product
changes, and clarifies requirements for product acceptance activities
quality data evaluations and corrections of nonconforming product/
quality problems.
Requirements are compatible with specifications in the
international standards ``ISO 9001: Quality Systems Model for Quality
Assurance in Design/Development, Production, Installation, and
Servicing.'' The CGMP/QS information collections will assist FDA
inspections of manufacturers for compliance with QS requirements
encompassing design, production, installation, and servicing processes.
Section 820.20(a) through (e) requires management with executive
responsibility to establish, maintain, and/or review the following
topics: (1) The quality policy, (2) the organizational structure, (3)
the quality plan, and (4) the quality system procedures of the
organization.
Section 820.22 requires the conduct and documentation of QS audits
and re-audits. Section 820.25(b) requires the establishment of
procedures to identify training needs and documentation of such
training.
Section 820.30(a)(1) and (b) through (j) requires, in respective
order, the establishment, maintenance, and/or documentation of the
following topics: (1) Procedures to control design of class III and
class II devices and certain class I devices as listed therein; (2)
plans for design and development activities and updates; (3) procedures
identifying, documenting, and approving design input requirements; (4)
procedures defining design output, including acceptance criteria, and
documentation of approved records; (5) procedures for formal review of
design results and documentation of results in the design history file
(DHF); (6) procedures for verifying device design and documentation of
results and approvals in the DHF; (7) procedures for validating device
design, including documentation of results in the DHF; (8) procedures
for translating device design into production specifications; (9)
procedures for documenting, verifying, and validating approved design
changes before implementation of changes; and (10) the records and
references constituting the DHF for each type of device.
Section 820.40 requires manufacturers to establish and maintain
procedures controlling approval and distribution of required documents
and document changes.
Section 820.40(a) and (b) requires the establishment and
maintenance of procedures for the review, approval, issuance, and
documentation of required records (documents) and changes to those
records.
Section 820.50(a) and (b) requires the establishment and
maintenance of procedures and requirements to ensure service and
product quality, records of acceptable suppliers, and purchasing data
describing specified requirements for products and services.
Sections 820.60 and 820.65 require, respectively, the establishment
and maintenance of procedures for identifying all products from receipt
to distribution and for using control numbers to track surgical
implants and life-sustaining or supporting devices and their
components.
Section 820.70(a) through (e), (g)(1) through (g)(3), (h), and (i)
requires the establishment, maintenance, and/or documentation of the
following topics: (1) Process control procedures; (2) procedures for
verifying or validating changes to specification, method, process, or
procedure; (3) procedures to control environmental conditions and
inspection result records; (4) requirements for personnel hygiene; (5)
procedures for preventing contamination of equipment and products; (6)
equipment adjustment, cleaning, and maintenance schedules; (7)
equipment inspection records; (8) equipment tolerance postings,
procedures for utilizing manufacturing materials expected to have an
adverse effect on product quality; and (9) validation protocols and
validation records for computer software and software changes.
Sections 820.72(a), (b)(1), and (b)(2) and 820.75(a) through (c)
require, respectively, the establishment, maintenance, and/or
documentation of the following topics: (1) Equipment calibration and
inspection procedures; (2) national, international, or in-house
calibration standards; (3) records that identify calibrated equipment
and next calibration dates; (4) validation procedures and validation
results for processes not verifiable by inspections and tests; (5)
procedures for keeping validated processes within specified
[[Page 46349]]
limits; (6) records for monitoring and controlling validated processes;
and (7) records of the results of revalidation where necessitated by
process changes or deviations.
Sections 820.80(a) through (e) and 820.86, respectively, require
the establishment, maintenance, and/or documentation of the following
topics: (1) Procedures for incoming acceptance by inspection, test, or
other verification; (2) procedures for ensuring that in process
products meet specified requirements and the control of product until
inspection and tests are completed; (3) procedures for, and records
that show, incoming acceptance or rejection is conducted by
inspections, tests or other verifications; (4) procedures for, and
records that show, finished devices meet acceptance criteria and are
not distributed until device master record (DMR) activities are
completed; (5) records in the device history record (DHR) showing
acceptance dates, results, and equipment used; and (6) the acceptance/
rejection identification of products from receipt to installation and
servicing.
Sections 820.90(a), (b)(1), and (b)(2) and 820.100 require,
respectively, the establishment, maintenance and/or documentation of
the following topics: (1) Procedures for identifying, recording,
evaluating, and disposing of nonconforming product; (2) procedures for
reviewing and recording concessions made for, and disposition of,
nonconforming product; (3) procedures for reworking products,
evaluating possible adverse rework effect and recording results in the
DHR; (4) procedures and requirements for corrective and preventive
actions, including analysis, investigation, identification and review
of data, records, causes, and results; and (5) records for all
corrective and preventive action activities.
Section 820.100(a)(1) through (a)(7) states that procedures and
requirements shall be established and maintained for corrective/
preventive actions, including the following: (1) Analysis of data from
process, work, quality, servicing records, investigation of
nonconformance causes; (2) identification of corrections and their
effectiveness; (3) recording of changes made; and (4) appropriate
distribution and managerial review of corrective and preventive action
information. Section 820.120 states that manufacturers shall establish/
maintain procedures to control labeling storage/application; and
examination/release for storage and use, and document those procedures.
Sections 820.120(b) and (d), 820.130, 820.140, 820.150(a) and (b),
820.160(a) and (b), and 820.170(a) and (b), respectively, require the
establishment, maintenance, and/or documentation of following topics:
(1) Procedures for controlling and recording the storage, examination,
release, and use of labeling; (2) the filing of labels/labeling used in
the DHR; (3) procedures for controlling product storage areas and
receipt/dispatch authorizations; (4) procedures controlling the release
of products for distribution; (5) distribution records that identify
consignee, product, date, and control numbers; and (6) instructions,
inspection and test procedures that are made available, and the
recording of results for devices requiring installation.
Sections 820.180(b) and (c), 820.181(a) through (e), 820.184(a)
through (f), and 820.186 require, respectively, the maintenance of
records that are: (1) Retained at prescribed site(s), made readily
available and accessible to FDA and retained for the device's life
expectancy or for 2 years; (2) contained or referenced in a DMR
consisting of device, process, quality assurance, packaging and
labeling, and installation, maintenance, and servicing specifications
and procedures; (3) contained in a DHR and demonstrate the manufacture
of each unit, lot, or batch of product in conformance with DMR and
regulatory requirements, include manufacturing and distribution dates,
quantities, acceptance documents, labels and labeling, control numbers;
and (4) contained in a quality system record, consisting of references,
documents, procedures, and activities not specific to particular
devices.
Sections 820.198(a) through (c) and 820.200(a) through (d),
respectively, require the establishment, maintenance, and/or
documentation of the following topics: (1) Complaint files and
procedures for receiving, reviewing and evaluating complaints; (2)
complaint investigation records identifying the device, complainant,
and relationship of the device to the incident; (3) complaint records
that are reasonably accessible to the manufacturing site or at
prescribed sites; (4) procedures for performing and verifying that
device servicing requirements are met and that service reports
involving complaints are processed as complaints; and (5) service
reports that record the device, service activity, and test and
inspection data.
Section 820.250 requires the establishment and maintenance of
procedures to identify valid statistical techniques necessary to verify
process and product acceptability; and sampling plans, when used, which
are written and based on valid statistical rationale; and procedures
for ensuring adequate sampling methods.
The CGMP/QS regulation added design and purchasing controls,
modified previous critical device requirements, revised previous
validation and other requirements, and harmonized device CGMP
requirements with QS specifications in the international standard ``ISO
9001: Quality Systems Model for Quality Assurance in Design/
Development, Production, Installation, and Servicing.'' The rule does
not apply to manufacturers of components or parts of finished devices,
or to manufacturers of human blood and blood components subject to 21
CFR part 606. With respect to devices classified in class I, design
control requirements apply only to class I devices listed in Sec.
820.30(a)(2) of the regulation. The rule imposes burden upon: (1)
Finished device manufacturer firms, which are subject to all
recordkeeping requirements; (2) finished device contract manufacturers,
specification developers; and (3) repacker, relabelers, and contract
sterilizer firms, which are subject only to requirements applicable to
their activities. In addition, remanufacturers of hospital single-use
devices (SUDs) are now to be considered to have the same requirements
as manufacturers in regard to the regulation. The establishment,
maintenance and/or documentation of procedures, records, and data
required by the regulation assists FDA in determining whether firms are
in compliance with CGMP requirements, which are intended to ensure that
devices meet their design, production, labeling, installation, and
servicing specifications and, thus are safe, effective, and suitable
for their intended purpose. In particular, compliance with CGMP design
control requirements should decrease the number of design-related
device failures that have resulted in deaths and serious injuries.
The CGMP/QS regulation applies to approximately 25,986 respondents.
A query of the Agency's registration and listing database shows that
approximately 15,113 domestic and 10,873 foreign establishments are
respondents to this information collection.\1\ These recordkeepers
consist of manufacturers, subject to all requirements and contract
manufacturers, specification developers, repackers, relabelers, and
contract sterilizers, subject only to requirements applicable to their
activities. Hospital remanufacturers of SUDs are now defined to be
manufacturers under guidance issued by FDA's Center for
[[Page 46350]]
Devices and Radiological Health, Office of Surveillance and Biometrics.
Respondents to this collection have no reporting activities, but must
make required records available for review or copying during FDA
inspection. Except for manufacturers, not every type of firm is subject
to every CGMP/QS requirement. For example, all are subject to Quality
Policy (Sec. 820.20(a)), Document Control (Sec. 820.40), and other
requirements, whereas only manufacturers and specification developers
are subject to subpart C, Design Controls. The PRA burden placed on the
25,986 establishments is an average burden.
---------------------------------------------------------------------------
\1\ Based on fiscal year 2012 data.
---------------------------------------------------------------------------
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR Section Number of recordkeepers records per Total annual records per Total hours
recordkeeper recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality policy--820.20(a).................... 25,986 1 25,986 7 181,902
Organization--820.20(b)...................... 25,986 1 25,986 4 103,944
Management review--820.20(c)................. 25,986 1 25,986 6 155,916
Quality planning--820.20(d).................. 25,986 1 25,986 10 259,860
Quality system procedures--820.20(e)......... 25,986 1 25,986 10 259,860
Quality audit--820.22........................ 25,986 1 25,986 33 857,538
Training--820.25(b).......................... 25,986 1 25,986 13 337,818
Design procedures--820.30(a)(1).............. 25,986 1 25,986 2 51,972
Design and development planning--820.30(b)... 25,986 1 25,986 6 155,916
Design input--820.30(c)...................... 25,986 1 25,986 2 51,972
Design output--820.30(d)..................... 25,986 1 25,986 2 51,972
Design review--820.30(e)..................... 25,986 1 25,986 23 597,678
Design verification--820.30(f)............... 25,986 1 25,986 37 961,482
Design validation--820.30(g)................. 25,986 1 25,986 37 961,482
Design transfer--820.30(h)................... 25,986 1 25,986 3 77,958
Design changes--820.30(i).................... 25,986 1 25,986 17 441,762
Design history file--820.30(j)............... 25,986 1 25,986 3 77,958
Document controls--820.40.................... 25,986 1 25,986 9 233,874
Documentation approval and distribution and 25,986 1 25,986 2 51,972
document changes--820.40(a) and (b).........
Purchasing controls--820.50(a)............... 25,986 1 25,986 22 571,692
Purchasing data--820.50(b)................... 25,986 1 25,986 6 155,916
Identification--820.60....................... 25,986 1 25,986 1 25,986
Traceability--820.65......................... 25,986 1 25,986 1 25,986
Production and process controls--820.70(a)... 25,986 1 25,986 2 51,972
Production and process changes and 25,986 1 25,986 2 51,972
environmental control--820.70(b) and (c)....
Personnel--820.70(d)......................... 25,986 1 25,986 3 77,958
Contamination control--820.70(e)............. 25,986 1 25,986 2 51,972
Equipment maintenance schedule, inspection, 25,986 1 25,986 1 25,986
and adjustment--820.70(g)(1) to (g)(3)......
Manufacturing material--820.70(h)............ 25,986 1 25,986 2 51,972
Automated processes--820.70(i)............... 25,986 1 25,986 8 207,888
Control of inspection, measuring, and test 25,986 1 25,986 5 129,930
equipment--820.72(a)........................
Calibration procedures, standards, and 25,986 1 25,986 1 25,986
records--820.72(b)(1) to (b)(2).............
Process validation--820.75(a)................ 25,986 1 25,986 3 77,958
Validated process parameters, monitoring, 25,986 1 25,986 1 25,986
control methods, and data--820.75(b)........
[[Page 46351]]
Revalidation--820.75(c)...................... 25,986 1 25,986 1 25,986
Acceptance activities--820.80(a) to (e)...... 25,986 1 25,986 5 129,930
Acceptance status--820.86.................... 25,986 1 25,986 1 25,986
Control of nonconforming product--820.90(a).. 25,986 1 25,986 5 129,930
Nonconforming product review/disposition 25,986 1 25,986 5 129,930
procedures and rework procedures--
820.90(b)(1) to (b)(2)......................
Procedures for corrective/preventive actions-- 25,986 1 25,986 12 311,832
820.100(a)(1) to (a)(7).....................
Corrective/preventive activities--820.100(b). 25,986 1 25,986 1 25,986
Labeling procedures--820.120(b).............. 25,986 1 25,986 1 25,986
Labeling documentation--820.120(d)........... 25,986 1 25,986 1 25,986
Device packaging--820.130.................... 25,986 1 25,986 1 25,986
Handling--820.140............................ 25,986 1 25,986 6 155,916
Storage--820.150(a) and (b).................. 25,986 1 25,986 6 155,916
Distribution procedures and records-- 25,986 1 25,986 1 25,986
820.160(a) and (b)..........................
Installation--820.170........................ 25,986 1 25,986 2 51,972
Record retention period--820.180(b) and (c).. 25,986 1 25,986 2 51,972
Device master record--820.181................ 25,986 1 25,986 1 25,986
Device history record--820.184............... 25,986 1 25,986 1 25,986
Quality system record--820.186............... 25,986 1 25,986 1 25,986
Complaint files--820.198(a), (c), and (g).... 25,986 1 25,986 5 129,930
Servicing procedures and reports--820.200(a) 25,986 1 25,986 3 77,958
and (d).....................................
Statistical techniques procedures and 25,986 1 25,986 1 25,986
sampling plans--820.250.....................
----------------------------------------------------------------------------------------------------------
Total.................................... ....................... .............. ....................... .............. 9,043,128
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18351 Filed 7-30-13; 8:45 am]
BILLING CODE 4160-01-P
