Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations, 62144-62148 [2016-21553]
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62144
ACTION:
Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that PREVACID IV
(lansoprazole) intravenous injection, 30
milligrams (mg)/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for lansoprazole
intravenous injection, 30 mg/vial, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Bronwen Blass, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993–0002, 301–
796–5092, Bronwen.blass@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
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SUMMARY:
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FDA may not approve an ANDA that
does not refer to a listed drug.
PREVACID IV (lansoprazole)
intravenous injection, 30 mg/vial, is the
subject of NDA 021566, held by Takeda
Pharmaceuticals North America, Inc.,
and initially approved on May 27, 2004.
The Indications and Usage section of the
PREVACID IV labeling states the
following: ‘‘When patients are unable to
take the oral formulations, PREVACID
I.V. for Injection is indicated as an
alternative for the short-term treatment
(up to 7 days) of all grades of erosive
esophagitis. Once the patient is able to
take medications orally, therapy can be
switched to an oral formulation of
PREVACID for a total of 6 to 8 weeks.
The safety and efficacy of PREVACID
I.V. for Injection as an initial treatment
of erosive esophagitis have not been
demonstrated. Refer to full prescribing
information for the oral formulations of
PREVACID.’’
In a letter dated February 5, 2007,
Takeda Pharmaceuticals North America,
Inc. notified FDA that PREVACID IV
(lansoprazole) intravenous injection, 30
mg/vial, was being discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Rose Zhao submitted a citizen
petition dated March 18, 2016 (Docket
No. FDA–2016–P–1037), under 21 CFR
10.30, requesting that the Agency
determine whether PREVACID IV
(lansoprazole) intravenous injection, 30
mg/vial, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that PREVACID IV
(lansoprazole) intravenous injection, 30
mg/vial, was not withdrawn for reasons
of safety or effectiveness. The petitioner
has identified no data or other
information suggesting that PREVACID
IV (lansoprazole) intravenous injection,
30 mg/vial, was withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
PREVACID IV (lansoprazole)
intravenous injection, 30 mg/vial, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list PREVACID IV
(lansoprazole) intravenous injection, 30
mg/vial, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
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Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to PREVACID IV
(lansoprazole) intravenous injection, 30
mg/vial, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21551 Filed 9–7–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device:
Current Good Manufacturing Practice
Quality System Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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).
SUMMARY:
Submit either electronic or
written comments on the collection of
information by November 7, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
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• 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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–N–2544 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device: Current Good Manufacturing
Practice Quality System Regulations.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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
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‘‘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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
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
SUPPLEMENTARY INFORMATION:
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62145
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
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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)
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.
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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
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
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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
the 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
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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, and 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 § 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, re-labelers, and contract
sterilizer firms, which are subject only
to requirements applicable to their
activities. In addition, remanufacturers
of hospital single-use devices are now
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 24,738 respondents. A
query of the Agency’s registration and
listing database shows that
approximately 13,294 domestic and
11,444 foreign establishments are
respondents to this information
collection.1 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 24,738
establishments is an average burden.
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
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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) ............................................
1 Based
Number of
records per
recordkeeper
Total annual
records
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Total hours
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
7
4
6
10
10
33
13
2
6
2
2
23
37
37
3
17
3
9
173,166
98,952
148,428
247,380
247,380
816,354
321,594
49,476
148,428
49,476
49,476
568,974
915,306
915,306
74,214
420,546
74,214
222,642
24,738
1
24,738
2
49,476
on fiscal year 2015 data.
VerDate Sep<11>2014
Average
burden per
recordkeeping
Fmt 4703
Sfmt 4703
E:\FR\FM\08SEN1.SGM
08SEN1
62148
Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Activity/21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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)–(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)–(b)(2) ...........................................................
Process validation—820.75(a) .............................................
Validated process parameters, monitoring, control methods, and data—820.75(b) ................................................
Revalidation—820.75(c) .......................................................
Acceptance activities—820.80(a)–(e) ..................................
Acceptance status—820.86 .................................................
Control of nonconforming product—820.90(a) ....................
Nonconforming product review/disposition procedures and
rework procedures—820.90(b)(1)–(b)(2) .........................
Procedures
for
corrective/preventive
actions—
820.100(a)(1)–(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 .............................................................................
24,738
24,738
24,738
24,738
24,738
1
1
1
1
1
24,738
24,738
24,738
24,738
24,738
22
6
1
1
2
544,236
148,428
24,738
24,738
49,476
24,738
24,738
24,738
1
1
1
24,738
24,738
24,738
2
3
2
49,476
74,214
49,476
24,738
24,738
24,738
1
1
1
24,738
24,738
24,738
1
2
8
24,738
49,476
197,904
24,738
1
24,738
5
123,690
24,738
24,738
1
1
24,738
24,738
1
3
24,738
74,214
24,738
24,738
24,738
24,738
24,738
1
1
1
1
1
24,738
24,738
24,738
24,738
24,738
1
1
5
1
5
24,738
24,738
123,690
24,738
123,690
24,738
1
24,738
5
123,690
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
24,738
12
1
1
1
1
6
6
1
2
2
1
1
1
5
3
296,856
24,738
24,738
24,738
24,738
148,428
148,428
24,738
49,476
49,476
24,738
24,738
24,738
123,690
74,214
24,738
1
24,738
1
24,738
Total ..............................................................................
........................
........................
........................
........................
8,410,920
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Notice; renewal of advisory
committee.
ACTION:
BILLING CODE 4164–01–P
mstockstill on DSK3G9T082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Oncologic Drugs
Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:34 Sep 07, 2016
Jkt 238001
The Food and Drug
Administration (FDA) is announcing the
renewal of the Oncologic Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Oncologic Drugs
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until September 1, 2018.
DATES: Authority for the Oncologic
Drugs Advisory Committee will expire
on September 1, 2016, unless the
SUMMARY:
[FR Doc. 2016–21553 Filed 9–7–16; 8:45 am]
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Lauren Tesh, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001,
ODAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 41
CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Oncologic Drugs Advisory Committee.
The committee is a discretionary
Federal advisory committee established
E:\FR\FM\08SEN1.SGM
08SEN1
]]>Agencies
[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62144-62148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21553]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2544]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device: Current Good Manufacturing Practice
Quality System Regulations
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 November 7, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 62145]]
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2544 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device: Current Good
Manufacturing Practice Quality System Regulations.''
Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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 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
[[Page 62146]]
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 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 the 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
[[Page 62147]]
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, and 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) re-packer, re-labelers, and contract
sterilizer firms, which are subject only to requirements applicable to
their activities. In addition, remanufacturers of hospital single-use
devices are now 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 24,738 respondents.
A query of the Agency's registration and listing database shows that
approximately 13,294 domestic and 11,444 foreign establishments are
respondents to this information collection.\1\ 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 24,738
establishments is an average burden.
---------------------------------------------------------------------------
\1\ Based on fiscal year 2015 data.
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Quality policy--820.20(a)....... 24,738 1 24,738 7 173,166
Organization--820.20(b)......... 24,738 1 24,738 4 98,952
Management review--820.20(c).... 24,738 1 24,738 6 148,428
Quality planning--820.20(d)..... 24,738 1 24,738 10 247,380
Quality system procedures-- 24,738 1 24,738 10 247,380
820.20(e)......................
Quality audit--820.22........... 24,738 1 24,738 33 816,354
Training--820.25(b)............. 24,738 1 24,738 13 321,594
Design procedures--820.30(a)(1). 24,738 1 24,738 2 49,476
Design and development planning-- 24,738 1 24,738 6 148,428
820.30(b)......................
Design input--820.30(c)......... 24,738 1 24,738 2 49,476
Design output--820.30(d)........ 24,738 1 24,738 2 49,476
Design review--820.30(e)........ 24,738 1 24,738 23 568,974
Design verification--820.30(f).. 24,738 1 24,738 37 915,306
Design validation--820.30(g).... 24,738 1 24,738 37 915,306
Design transfer--820.30(h)...... 24,738 1 24,738 3 74,214
Design changes--820.30(i)....... 24,738 1 24,738 17 420,546
Design history file--820.30(j).. 24,738 1 24,738 3 74,214
Document controls--820.40....... 24,738 1 24,738 9 222,642
Documentation approval and 24,738 1 24,738 2 49,476
distribution and document
changes--820.40(a) and (b).....
[[Page 62148]]
Purchasing controls--820.50(a).. 24,738 1 24,738 22 544,236
Purchasing data--820.50(b)...... 24,738 1 24,738 6 148,428
Identification--820.60.......... 24,738 1 24,738 1 24,738
Traceability--820.65............ 24,738 1 24,738 1 24,738
Production and process controls-- 24,738 1 24,738 2 49,476
820.70(a)......................
Production and process changes 24,738 1 24,738 2 49,476
and environmental control--
820.70(b) and (c)..............
Personnel--820.70(d)............ 24,738 1 24,738 3 74,214
Contamination control--820.70(e) 24,738 1 24,738 2 49,476
Equipment maintenance schedule, 24,738 1 24,738 1 24,738
inspection, and adjustment--
820.70(g)(1)-(g)(3)............
Manufacturing material-- 24,738 1 24,738 2 49,476
820.70(h)......................
Automated processes--820.70(i).. 24,738 1 24,738 8 197,904
Control of inspection, 24,738 1 24,738 5 123,690
measuring, and test equipment--
820.72(a)......................
Calibration procedures, 24,738 1 24,738 1 24,738
standards, and records--
820.72(b)(1)-(b)(2)............
Process validation--820.75(a)... 24,738 1 24,738 3 74,214
Validated process parameters, 24,738 1 24,738 1 24,738
monitoring, control methods,
and data--820.75(b)............
Revalidation--820.75(c)......... 24,738 1 24,738 1 24,738
Acceptance activities--820.80(a)- 24,738 1 24,738 5 123,690
(e)............................
Acceptance status--820.86....... 24,738 1 24,738 1 24,738
Control of nonconforming 24,738 1 24,738 5 123,690
product--820.90(a).............
Nonconforming product review/ 24,738 1 24,738 5 123,690
disposition procedures and
rework procedures--820.90(b)(1)-
(b)(2).........................
Procedures for corrective/ 24,738 1 24,738 12 296,856
preventive actions--
820.100(a)(1)-(a)(7)...........
Corrective/preventive 24,738 1 24,738 1 24,738
activities--820.100(b).........
Labeling procedures--820.120(b). 24,738 1 24,738 1 24,738
Labeling documentation-- 24,738 1 24,738 1 24,738
820.120(d).....................
Device packaging--820.130....... 24,738 1 24,738 1 24,738
Handling--820.140............... 24,738 1 24,738 6 148,428
Storage--820.150(a) and (b)..... 24,738 1 24,738 6 148,428
Distribution procedures and 24,738 1 24,738 1 24,738
records--820.160(a) and (b)....
Installation--820.170........... 24,738 1 24,738 2 49,476
Record retention period-- 24,738 1 24,738 2 49,476
820.180(b) and (c).............
Device master record--820.181... 24,738 1 24,738 1 24,738
Device history record--820.184.. 24,738 1 24,738 1 24,738
Quality system record--820.186.. 24,738 1 24,738 1 24,738
Complaint files--820.198(a), 24,738 1 24,738 5 123,690
(c), and (g)...................
Servicing procedures and 24,738 1 24,738 3 74,214
reports--820.200(a) and (d)....
Statistical techniques 24,738 1 24,738 1 24,738
procedures and sampling plans--
820.250........................
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Total....................... .............. .............. .............. .............. 8,410,920
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21553 Filed 9-7-16; 8:45 am]
BILLING CODE 4164-01-P
