Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, 58811-58815 [2017-26932]
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Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0362]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed 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 the information
collection for the Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals.
DATES: Submit either electronic or
written comments on the collection of
information by February 12, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 12,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 12, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
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anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0362 for ‘‘Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff office
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 Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
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58811
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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)
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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.
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Current Good Manufacturing Practice
Regulations for Finished
Pharmaceuticals (21 CFR Parts 210 and
211)
OMB Control Number 0910–0139—
Extension
This information collection supports
FDA regulations. Specifically, under
section 501(a)(2)(B) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 351(a)(2)(B)), a drug is
adulterated if the methods used in or
the facilities or controls used for its
manufacture, processing, packing, or
holding do not conform to or are not
operated or administered in conformity
with Current Good Manufacturing
Practice (CGMP). The CGMP regulations
help ensure drug products meet the
statutory requirements for safety and
have their purported or represented
identity, strength, quality, and purity
characteristics. The information
collection requirements in the CGMP
regulations provide FDA with the
necessary information to perform its
duty to protect public health and safety.
CGMP requirements establish
accountability for manufacturing and
processing drug products, provide for
meaningful FDA inspections, and
enable manufacturers to improve the
quality of drug products over time. The
CGMP recordkeeping requirements also
serve preventive and remedial purposes
and provide crucial information if it is
necessary to recall a drug product.
The general requirements for
recordkeeping under part 211 (21 CFR
part 211) are set forth in § 211.180. Any
production, control, or distribution
record associated with a batch and
required to be maintained in
compliance with part 211 must be
retained for at least 1 year after the
expiration date of the batch and, for
certain over-the-counter (OTC) drugs, 3
years after distribution of the batch
(§ 211.180(a)). Records for all
components, drug product containers,
closures, and labeling are required to be
maintained for at least 1 year after the
expiration date and 3 years for certain
OTC products (§ 211.180(b)).
All part 211 records must be readily
available for authorized inspections
during the retention period
(§ 211.180(c)), and such records may be
retained either as original records or as
true copies (§ 211.180(d)). Additionally,
§ 11.2(a) (21 CFR 11.2(a)) provides that
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‘‘for records required to be maintained
but not submitted to the Agency,
persons may use electronic records in
lieu of paper records or electronic
signatures in lieu of traditional
signatures, in whole or in part, provided
that the requirements of this part are
met.’’ To the extent this electronic
option is used, the burden of
maintaining paper records should be
substantially reduced, as should any
review of such records.
To facilitate improvements and
corrective actions, records must be
maintained so data can be used to
evaluate the quality standards of each
drug product on at least an annual basis
and determine whether to change any
drug product specifications or
manufacturing or control procedures
(§ 211.180(e)). Written procedures for
these evaluations are to be established
and include provisions for a review of
a representative number of batches and,
where applicable, records associated
with the batch; provisions for a review
of complaints, recalls, returned or
salvaged drug products; and
investigations conducted under
§ 211.192 for each drug product.
The specific information collection
provisions are as follows:
• Section 211.34—Consultants
advising on the manufacture,
processing, packing, or holding of drug
products must have sufficient
education, training, and experience to
advise on the subject for which they are
retained. Records must be maintained
stating the name, address, and
qualifications of any consultants and the
type of service they provide.
• Section 211.67(c)—Records must be
kept of maintenance, cleaning,
sanitizing, and inspection as specified
in §§ 211.180 and 211.182.
• Section 211.68—Appropriate
controls must be exercised over
computer or related systems to assure
that changes in master production and
control records or other records are
instituted only by authorized personnel.
• Section 211.68(a)—Records must be
maintained of calibration checks,
inspections, and computer or related
system programs for automatic,
mechanical, and electronic equipment.
• Section 211.68(b)—All appropriate
controls must be exercised over all
computers or related systems and
control data systems to assure that
changes in master production and
control records or other records are
instituted only by authorized persons.
• Section 211.72—Filters for liquid
filtration used in the manufacture,
processing, or packing of injectable drug
products intended for human use must
not release fibers into such products.
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• Section 211.80(d)—Each container
or grouping of containers for
components or drug product containers
or closures must be identified with a
distinctive code for each lot in each
shipment received. This code must be
used in recording the disposition of
each lot. Each lot must be appropriately
identified as to its status.
• Section 211.100(b)—Written
production and process control
procedures must be followed in the
execution of the various production and
process control functions and must be
documented at the time of performance.
Any deviation from the written
procedures must be recorded and
justified.
• Section 211.105(b)—Major
equipment must be identified by a
distinctive identification number or
code that must be recorded in the batch
production record to show the specific
equipment used in the manufacture of
each batch of a drug product. In cases
where only one of a particular type of
equipment exists in a manufacturing
facility, the name of the equipment may
be used in lieu of a distinctive
identification number or code.
• Section 211.122(c)—Records must
be maintained for each shipment
received of each different labeling and
packaging material indicating receipt,
examination, or testing.
• Section 211.130(e)—Inspection of
packaging and labeling facilities must be
made immediately before use to assure
that all drug products have been
removed from previous operations.
Inspection must also be made to assure
that packaging and labeling materials
not suitable for subsequent operations
have been removed. Results of
inspection must be documented in the
batch production records.
• Section 211.132(c)—Certain retail
packages of OTC drug products must
bear a statement that is prominently
placed so consumers are alerted to the
specific tamper-evident feature of the
package. The labeling statement is
required to be so placed that it will be
unaffected if the tamper-resistant feature
of the package is breached or missing.
If the tamper-evident feature chosen is
one that uses an identifying
characteristic, that characteristic is
required to be referred to in the labeling
statement.
• Section 211.132(d)—A request for
an exemption from packaging and
labeling requirements by a manufacturer
or packer is required to be submitted in
the form of a citizen petition under 21
CFR 10.30.
• Section 211.137—Requirements
regarding product expiration dating and
compliance with 21 CFR 201.17.
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• Section 211.160(a)—The
establishment of any specifications,
standards, sampling plans, test
procedures, or other laboratory control
mechanisms, including any change in
such specifications, standards, sampling
plans, test procedures, or other
laboratory control mechanisms, must be
drafted by the appropriate
organizational unit and reviewed and
approved by the quality control unit.
These requirements must be followed
and documented at the time of
performance. Any deviation from the
written specifications, standards,
sampling plans, test procedures, or
other laboratory control mechanisms
must be recorded and justified.
• Section 211.165(e)—The accuracy,
sensitivity, specificity, and
reproducibility of test methods
employed by a firm must be established
and documented. Such validation and
documentation may be accomplished in
accordance with § 211.194(a)(2).
• Section 211.166—Stability testing
program for drug products.
• Section 211.173—Animals used in
testing components, in-process
materials, or drug products for
compliance with established
specifications must be maintained and
controlled in a manner that assures their
suitability for their intended use. They
must be identified, and adequate
records must be maintained showing the
history of their use.
• Section 211.180(e)—Written
records required by part 211 must be
maintained so that data can be used for
evaluating, at least annually, the quality
standards of each drug product to
determine the need for changes in drug
product specifications or manufacturing
or control procedures. Written
procedures must be established and
followed for such evaluations and must
include provisions for a representative
number of batches, whether approved or
unapproved or rejected, and a review of
complaints, recalls, returned or salvaged
drug products, and investigations
conducted under § 211.192 for each
drug product.
• Section 211.180(f)—Procedures
must be established to assure that the
responsible officials of the firm, if they
are not personally involved in or
immediately aware of such actions, are
notified in writing of any investigations,
conducted under § 211.198, § 211.204,
or § 211.208, any recalls, reports of
inspectional observations issued, or any
regulatory actions relating to good
manufacturing practices brought by
FDA.
• Section 211.182—Specifies
requirements for equipment cleaning
records and the use log.
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• Section 211.184—Specifies
requirements for component, drug
product container, closure, and labeling
records.
• Section 211.186—Specifies master
production and control records
requirements.
• Section 211.188—Specifies batch
production and control records
requirement.
• Section 211.192—Specifies the
information that must be maintained on
the investigation of discrepancies found
in the review of all drug product
production and control records by the
quality control staff.
• Section 211.194—Explains and
describes laboratory records that must
be retained.
• Section 211.196—Specifies the
information that must be included in
records on the distribution of the drug.
• Section 211.198—Specifies and
describes the handling of all complaint
files received by the applicant.
• Section 211.204—Specifies that
records be maintained of returned and
salvaged drug products and describes
the procedures involved.
Written procedures, referred to here
as standard operating procedures
(SOPs), are required for many part 211
records. Current SOP requirements were
initially provided in a final rule
published in the Federal Register of
September 29, 1978 (43 FR 45014), and
are now an integral and familiar part of
the drug manufacturing process. The
major information collection impact of
SOPs results from their creation.
Thereafter, SOPs need to be periodically
updated. A combined estimate for
routine maintenance of SOPs is
provided in table 1. The 25 SOP
provisions under part 211 in the
combined maintenance estimate
include:
• Section 211.22(d)—Responsibilities
and procedures of the quality control
unit;
• Section 211.56(b)—Sanitation
procedures;
• Section 211.56(c)—Use of suitable
rodenticides, insecticides, fungicides,
fumigating agents, and cleaning and
sanitizing agents;
• Section 211.67(b)—Cleaning and
maintenance of equipment;
• Section 211.68(a)—Proper
performance of automatic, mechanical,
and electronic equipment;
• Section 211.80(a)—Receipt,
identification, storage, handling,
sampling, testing, and approval or
rejection of components and drug
product containers or closures;
• Section 211.94(d)—Standards or
specifications, methods of testing, and
methods of cleaning, sterilizing, and
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processing to remove pyrogenic
properties for drug product containers
and closures;
• Section 211.100(a)—Production and
process control;
• Section 211.110(a)—Sampling and
testing of in-process materials and drug
products;
• Section 211.113(a)—Prevention of
objectionable microorganisms in drug
products not required to be sterile;
• Section 211.113(b)—Prevention of
microbiological contamination of drug
products purporting to be sterile,
including validation of any sterilization
process;
• Section 211.115(a)—System for
reprocessing batches that do not
conform to standards or specifications
to insure that reprocessed batches
conform with all established standards,
specifications, and characteristics;
• Section 211.122(a)—Receipt,
identification, storage, handling,
sampling, examination and/or testing of
labeling and packaging materials;
• Section 211.125(f)—Control
procedures for the issuance of labeling;
• Section 211.130—Packaging and
label operations, prevention of mixup
and cross contamination, identification
and handling of filed drug product
containers that are set aside and held in
unlabeled condition, and identification
of the drug product with a lot or control
number that permits determination of
the history of the manufacture and
control of the batch;
• Section 211.142—Warehousing;
• Section 211.150—Distribution of
drug products;
• Section 211.160—Laboratory
controls;
• Section 211.165(c)—Testing and
release for distribution;
• Section 211.166(a)—Stability
testing;
• Section 211.167—Special testing
requirements;
• Section 211.180(f)—Notification of
responsible officials of investigations,
recalls, reports of inspectional
observations, and any regulatory actions
relating to good manufacturing practice;
• Section 211.198(a)—Written and
oral complaint procedures, including
quality control unit review of any
complaint involving specifications
failures, and serious and unexpected
adverse drug experiences;
• Section 211.204—Holding, testing,
and reprocessing of returned drug
products; and
• Section 211.208—Drug product
salvaging.
In addition, the following regulations
in parts 610 and 680 (21 CFR parts 610
and 680) reference certain CGMP
regulations in part 211: §§ 610.12(g),
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Although most CGMP provisions
covered in this document were created
many years ago, some existing firms
expanding into new manufacturing
areas and startup firms will need to
create SOPs. As provided in table 1,
FDA assumes approximately 50 firms
610.13(a)(2), 610.18(d), 680.2(f), and
680.3(f). In table 1, the burden
associated with the information
collection requirements in these
regulations is included in the burden
estimates under §§ 211.165, 211.167,
211.188, and 211.194, as appropriate.
will have to create up to 25 SOPs for a
total of 1,250 records, estimating 20
hours per recordkeeper to create 25 new
SOPs for a total of 25,000 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section/activity
SOP Maintenance ................................................................
New Startup SOPs ...............................................................
211.34—Consultants ............................................................
211.67(c)—Equipment cleaning and maintenance ..............
211.68—Changes in master production and control
records or other records ...................................................
211.68(a)—Automatic, mechanical, and electronic equipment ..................................................................................
211.68(b)—Computer or related systems ...........................
211.72—Filters .....................................................................
211.80(d)—Components and drug product containers or
closures ............................................................................
211.100(b)—Production and process controls ....................
211.105(b)—Equipment identification ..................................
211.122(c)—Labeling and packaging material ....................
211.130(e)—Labeling and packaging facilities ....................
211.132(c)—Tamper-evident packaging ..............................
211.132(d)—Tamper-evident packaging .............................
211.137—Expiration dating ..................................................
211.160(a)—Laboratory controls .........................................
211.165(e)—Test methodology ...........................................
211.166—Stability testing ....................................................
211.173—Laboratory animals ..............................................
211.180(e)—Production, control, and distribution records ..
211.180(f)—Procedures for notification of regulatory actions ..................................................................................
211.182—Equipment cleaning and use log .........................
211.184—Component, drug product container, closure,
and labeling records .........................................................
211.186—Master production and control records ...............
211.188—Batch production and control records .................
211.192—Discrepancies in drug product production and
control records ..................................................................
211.194—Laboratory records ..............................................
211.196—Distribution records .............................................
211.198—Compliant files .....................................................
211.204—Returned drug products ......................................
Total ..............................................................................
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1 Burden
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours) 1
Total hours
3,270
50
3,270
3,270
........................
25
0.25
50
3,270
1,250
818
163,500
25
20
5
0.25
81,750
25,000
4090
40,875
3,270
2
6,540
1
6,540
3,270
3,270
416
10
5
0.25
32,700
16,350
104
0.5
0.25
1
16,350
4,088
104
3,270
3,270
3,270
3,270
3,270
1,613
1,613
3,270
3,270
3,270
3,270
33
3,270
0.25
3
0.25
50
50
20
0.2
5
2
1
2
1
0.2
818
9,810
818
163,500
163,500
32,260
323
16,350
6,540
3,270
6,540
33
654
0.1
2
0.25
0.25
0.25
0.5
0.5
0.5
1
1
0.5
0.25
0.25
82
19,620
205
40,875
40,875
16,130
162
8,175
6,540
3,270
3,270
8
164
3,270
3,270
0.2
2
654
6,540
1
0.25
654
1,635
3,270
3,270
3,270
3
10
25
9,810
32,700
81,750
0.5
2
2
4,905
65,400
163,500
3,270
3,270
3,270
3,270
3,270
2
25
25
5
10
6,540
81,750
81,750
16,350
32,700
1
0.5
0.25
1
0.5
6,540
40,875
20,438
16,350
16,350
........................
........................
........................
........................
651,139
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
The recordkeeping requirement
estimates provided in table 2 are
specific to medical gases. In particular,
on June 29, 2017, FDA published a
Notice of Availability (NOA) in the
Federal Register regarding revised draft
guidance for industry entitled ‘‘Current
Good Manufacturing Practice for
Medical Gases’’ (82 FR 29565). This
guidance is intended to help medical
gas manufacturers comply with
applicable CGMP regulations found in
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parts 210 and 211. In the NOA for the
revised draft guidance, FDA noted the
guidance includes information
collection provisions subject to review
by the OMB under the PRA and, in
accordance with the PRA, before
publication of the final guidance, FDA
intends to solicit public comment and
obtain OMB approval for any
recommended new information
collections or material modifications to
previously approved collections of
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information found in FDA regulations.
This notice is intended to solicit such
public comment.
The regulations addressed in table 2
are the same as those listed in table 1,
but the estimated information collection
burden differs and is specific to medical
gas manufacturing. FDA estimates the
burden of this collection of information
as follows:
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN (MEDICAL GASES) 1
Number of
recordkeepers
21 CFR section/activity
SOP Maintenance ................................................................
New startup SOPs ...............................................................
211.34—Consultants ............................................................
211.67(c)—Equipment cleaning and maintenance ..............
211.68—Changes in master production and control
records or other records ...................................................
211.68(a)—Automatic, mechanical, and electronic equipment ..................................................................................
211.68(b)—Computer or related systems ...........................
211.72—Filters .....................................................................
211.80(d)—Components and drug product containers or
closures ............................................................................
211.100(b)—Production and process controls ....................
211.105(b)—Equipment identification ..................................
211.122(c)—Labeling and packaging material ....................
211.130(e)—Labeling and packaging facilities ....................
211.132(c)—Tamper-evident packaging ..............................
211.132(d)—Tamper-evident packaging .............................
211.137—Expiration dating ..................................................
211.160(a)—Laboratory controls .........................................
211.165(e)—Test methodology ...........................................
211.166—Stability testing ....................................................
211.173—Laboratory animals ..............................................
211.180(e)—Production, control, and distribution records ..
211.180(f)—Procedures for notification of regulatory actions ..................................................................................
211.182—Equipment cleaning and use log .........................
211.184—Component, drug product container, closure,
and labeling records .........................................................
211.186—Master production and control records ...............
211.188—Batch production and control records .................
211.192—Discrepancies in drug product production and
control records ..................................................................
211.194—Laboratory records ..............................................
211.196—Distribution records .............................................
211.198—Complaint files .....................................................
211.204—Returned drug products ......................................
Total ..............................................................................
1 Burden
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Total hours
0.65
25
0.25
32.5
1,485
2,500
571
74,230
25
20
0.5
0.25
37,125
50,000
286
18,558
2,284
2
4,568
1
4,568
2,284
2,284
2,284
10
5
0.25
22,840
11,420
571
0.5
0.25
1
11,420
2,855
571
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
0.25
3
0.25
50
50
20
0.2
3.25
2
1
1.3
1
0.2
571
6,382
571
114,200
114,200
45,680
457
7,423
4,568
2,284
2,969
2,284
457
0.1
2
0.25
0.25
0.25
0.5
0.5
0.33
1
1
0.33
0.25
0.25
57
13,704
143
28,550
28,550
22,840
229
2,450
4,568
2,284
980
571
114
2,284
2,284
0.2
1.3
457
2,969
1
0.16
457
475
2,284
2,284
2,284
1.95
10
16.25
4,454
22,840
37,115
0.33
2
1.3
1,470
45,680
48,250
2,284
2,284
2,284
2,284
2,284
2
25
25
5
10
4,568
57,100
57,100
11,420
22,840
1
0.5
0.25
1
0.5
4,568
28,550
14,275
11,420
11,420
........................
........................
........................
........................
396,988
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2015–D–4562]
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
recordkeeping
(in hours) 1
2,284
100
2,284
2,284
Investigational New Drug Safety
Reporting; Public Workshop’’ that
appeared in the Federal Register of
November 27, 2017. The document
announced a public workshop to engage
external stakeholders in discussions
related to finalizing the draft guidance
entitled ‘‘Safety Assessment for IND
Safety Reporting.’’ The date of the
meeting has changed.
[FR Doc. 2017–26932 Filed 12–13–17; 8:45 am]
Public Workshop on Safety
Assessment for Investigational New
Drug Safety Reporting; Correction
Food and Drug Administration,
HHS.
ACTION:
Total annual
records
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Number of
records per
recordkeeper
Notice; correction.
The Food and Drug
Administration is correcting a notice
entitled ‘‘Safety Assessment for
SUMMARY:
VerDate Sep<11>2014
21:28 Dec 13, 2017
Jkt 244001
held on January 11, 2018, from 9 a.m.
to 4 p.m., Eastern Time.’’ is corrected to
read ‘‘The public workshop will be held
on March 8, 2018, from 9 a.m. to 4 p.m.,
Eastern Time.’’
Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26938 Filed 12–13–17; 8:45 am]
BILLING CODE 4164–01–P
Lauren Wedlake, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6362,
Silver Spring, MD 20993, 301–796–
2728, Lauren.Wedlake@fda.hhs.gov.
In the Federal Register of Monday,
November 27, 2017, in FR Doc. 2017–
25454, the following correction is made:
1. On page 56036, in the first column,
in the first sentence of the DATES
section, ‘‘The public workshop will be
PO 00000
Frm 00024
Fmt 4703
Sfmt 9990
E:\FR\FM\14DEN1.SGM
14DEN1
Agencies
[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58811-58815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26932]
[[Page 58811]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0362]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Finished Pharmaceuticals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed 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 the information collection for the Current
Good Manufacturing Practice Regulations for Finished Pharmaceuticals.
DATES: Submit either electronic or written comments on the collection
of information by February 12, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 12, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0362 for ``Current Good Manufacturing Practice Regulations
for Finished Pharmaceuticals.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
office 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 Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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)
[[Page 58812]]
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Current Good Manufacturing Practice Regulations for Finished
Pharmaceuticals (21 CFR Parts 210 and 211)
OMB Control Number 0910-0139--Extension
This information collection supports FDA regulations. Specifically,
under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the
methods used in or the facilities or controls used for its manufacture,
processing, packing, or holding do not conform to or are not operated
or administered in conformity with Current Good Manufacturing Practice
(CGMP). The CGMP regulations help ensure drug products meet the
statutory requirements for safety and have their purported or
represented identity, strength, quality, and purity characteristics.
The information collection requirements in the CGMP regulations provide
FDA with the necessary information to perform its duty to protect
public health and safety. CGMP requirements establish accountability
for manufacturing and processing drug products, provide for meaningful
FDA inspections, and enable manufacturers to improve the quality of
drug products over time. The CGMP recordkeeping requirements also serve
preventive and remedial purposes and provide crucial information if it
is necessary to recall a drug product.
The general requirements for recordkeeping under part 211 (21 CFR
part 211) are set forth in Sec. 211.180. Any production, control, or
distribution record associated with a batch and required to be
maintained in compliance with part 211 must be retained for at least 1
year after the expiration date of the batch and, for certain over-the-
counter (OTC) drugs, 3 years after distribution of the batch (Sec.
211.180(a)). Records for all components, drug product containers,
closures, and labeling are required to be maintained for at least 1
year after the expiration date and 3 years for certain OTC products
(Sec. 211.180(b)).
All part 211 records must be readily available for authorized
inspections during the retention period (Sec. 211.180(c)), and such
records may be retained either as original records or as true copies
(Sec. 211.180(d)). Additionally, Sec. 11.2(a) (21 CFR 11.2(a))
provides that ``for records required to be maintained but not submitted
to the Agency, persons may use electronic records in lieu of paper
records or electronic signatures in lieu of traditional signatures, in
whole or in part, provided that the requirements of this part are
met.'' To the extent this electronic option is used, the burden of
maintaining paper records should be substantially reduced, as should
any review of such records.
To facilitate improvements and corrective actions, records must be
maintained so data can be used to evaluate the quality standards of
each drug product on at least an annual basis and determine whether to
change any drug product specifications or manufacturing or control
procedures (Sec. 211.180(e)). Written procedures for these evaluations
are to be established and include provisions for a review of a
representative number of batches and, where applicable, records
associated with the batch; provisions for a review of complaints,
recalls, returned or salvaged drug products; and investigations
conducted under Sec. 211.192 for each drug product.
The specific information collection provisions are as follows:
Section 211.34--Consultants advising on the manufacture,
processing, packing, or holding of drug products must have sufficient
education, training, and experience to advise on the subject for which
they are retained. Records must be maintained stating the name,
address, and qualifications of any consultants and the type of service
they provide.
Section 211.67(c)--Records must be kept of maintenance,
cleaning, sanitizing, and inspection as specified in Sec. Sec. 211.180
and 211.182.
Section 211.68--Appropriate controls must be exercised
over computer or related systems to assure that changes in master
production and control records or other records are instituted only by
authorized personnel.
Section 211.68(a)--Records must be maintained of
calibration checks, inspections, and computer or related system
programs for automatic, mechanical, and electronic equipment.
Section 211.68(b)--All appropriate controls must be
exercised over all computers or related systems and control data
systems to assure that changes in master production and control records
or other records are instituted only by authorized persons.
Section 211.72--Filters for liquid filtration used in the
manufacture, processing, or packing of injectable drug products
intended for human use must not release fibers into such products.
Section 211.80(d)--Each container or grouping of
containers for components or drug product containers or closures must
be identified with a distinctive code for each lot in each shipment
received. This code must be used in recording the disposition of each
lot. Each lot must be appropriately identified as to its status.
Section 211.100(b)--Written production and process control
procedures must be followed in the execution of the various production
and process control functions and must be documented at the time of
performance. Any deviation from the written procedures must be recorded
and justified.
Section 211.105(b)--Major equipment must be identified by
a distinctive identification number or code that must be recorded in
the batch production record to show the specific equipment used in the
manufacture of each batch of a drug product. In cases where only one of
a particular type of equipment exists in a manufacturing facility, the
name of the equipment may be used in lieu of a distinctive
identification number or code.
Section 211.122(c)--Records must be maintained for each
shipment received of each different labeling and packaging material
indicating receipt, examination, or testing.
Section 211.130(e)--Inspection of packaging and labeling
facilities must be made immediately before use to assure that all drug
products have been removed from previous operations. Inspection must
also be made to assure that packaging and labeling materials not
suitable for subsequent operations have been removed. Results of
inspection must be documented in the batch production records.
Section 211.132(c)--Certain retail packages of OTC drug
products must bear a statement that is prominently placed so consumers
are alerted to the specific tamper-evident feature of the package. The
labeling statement is required to be so placed that it will be
unaffected if the tamper-resistant feature of the package is breached
or missing. If the tamper-evident feature chosen is one that uses an
identifying characteristic, that characteristic is required to be
referred to in the labeling statement.
Section 211.132(d)--A request for an exemption from
packaging and labeling requirements by a manufacturer or packer is
required to be submitted in the form of a citizen petition under 21 CFR
10.30.
Section 211.137--Requirements regarding product expiration
dating and compliance with 21 CFR 201.17.
[[Page 58813]]
Section 211.160(a)--The establishment of any
specifications, standards, sampling plans, test procedures, or other
laboratory control mechanisms, including any change in such
specifications, standards, sampling plans, test procedures, or other
laboratory control mechanisms, must be drafted by the appropriate
organizational unit and reviewed and approved by the quality control
unit. These requirements must be followed and documented at the time of
performance. Any deviation from the written specifications, standards,
sampling plans, test procedures, or other laboratory control mechanisms
must be recorded and justified.
Section 211.165(e)--The accuracy, sensitivity,
specificity, and reproducibility of test methods employed by a firm
must be established and documented. Such validation and documentation
may be accomplished in accordance with Sec. 211.194(a)(2).
Section 211.166--Stability testing program for drug
products.
Section 211.173--Animals used in testing components, in-
process materials, or drug products for compliance with established
specifications must be maintained and controlled in a manner that
assures their suitability for their intended use. They must be
identified, and adequate records must be maintained showing the history
of their use.
Section 211.180(e)--Written records required by part 211
must be maintained so that data can be used for evaluating, at least
annually, the quality standards of each drug product to determine the
need for changes in drug product specifications or manufacturing or
control procedures. Written procedures must be established and followed
for such evaluations and must include provisions for a representative
number of batches, whether approved or unapproved or rejected, and a
review of complaints, recalls, returned or salvaged drug products, and
investigations conducted under Sec. 211.192 for each drug product.
Section 211.180(f)--Procedures must be established to
assure that the responsible officials of the firm, if they are not
personally involved in or immediately aware of such actions, are
notified in writing of any investigations, conducted under Sec.
211.198, Sec. 211.204, or Sec. 211.208, any recalls, reports of
inspectional observations issued, or any regulatory actions relating to
good manufacturing practices brought by FDA.
Section 211.182--Specifies requirements for equipment
cleaning records and the use log.
Section 211.184--Specifies requirements for component,
drug product container, closure, and labeling records.
Section 211.186--Specifies master production and control
records requirements.
Section 211.188--Specifies batch production and control
records requirement.
Section 211.192--Specifies the information that must be
maintained on the investigation of discrepancies found in the review of
all drug product production and control records by the quality control
staff.
Section 211.194--Explains and describes laboratory records
that must be retained.
Section 211.196--Specifies the information that must be
included in records on the distribution of the drug.
Section 211.198--Specifies and describes the handling of
all complaint files received by the applicant.
Section 211.204--Specifies that records be maintained of
returned and salvaged drug products and describes the procedures
involved.
Written procedures, referred to here as standard operating
procedures (SOPs), are required for many part 211 records. Current SOP
requirements were initially provided in a final rule published in the
Federal Register of September 29, 1978 (43 FR 45014), and are now an
integral and familiar part of the drug manufacturing process. The major
information collection impact of SOPs results from their creation.
Thereafter, SOPs need to be periodically updated. A combined estimate
for routine maintenance of SOPs is provided in table 1. The 25 SOP
provisions under part 211 in the combined maintenance estimate include:
Section 211.22(d)--Responsibilities and procedures of the
quality control unit;
Section 211.56(b)--Sanitation procedures;
Section 211.56(c)--Use of suitable rodenticides,
insecticides, fungicides, fumigating agents, and cleaning and
sanitizing agents;
Section 211.67(b)--Cleaning and maintenance of equipment;
Section 211.68(a)--Proper performance of automatic,
mechanical, and electronic equipment;
Section 211.80(a)--Receipt, identification, storage,
handling, sampling, testing, and approval or rejection of components
and drug product containers or closures;
Section 211.94(d)--Standards or specifications, methods of
testing, and methods of cleaning, sterilizing, and processing to remove
pyrogenic properties for drug product containers and closures;
Section 211.100(a)--Production and process control;
Section 211.110(a)--Sampling and testing of in-process
materials and drug products;
Section 211.113(a)--Prevention of objectionable
microorganisms in drug products not required to be sterile;
Section 211.113(b)--Prevention of microbiological
contamination of drug products purporting to be sterile, including
validation of any sterilization process;
Section 211.115(a)--System for reprocessing batches that
do not conform to standards or specifications to insure that
reprocessed batches conform with all established standards,
specifications, and characteristics;
Section 211.122(a)--Receipt, identification, storage,
handling, sampling, examination and/or testing of labeling and
packaging materials;
Section 211.125(f)--Control procedures for the issuance of
labeling;
Section 211.130--Packaging and label operations,
prevention of mixup and cross contamination, identification and
handling of filed drug product containers that are set aside and held
in unlabeled condition, and identification of the drug product with a
lot or control number that permits determination of the history of the
manufacture and control of the batch;
Section 211.142--Warehousing;
Section 211.150--Distribution of drug products;
Section 211.160--Laboratory controls;
Section 211.165(c)--Testing and release for distribution;
Section 211.166(a)--Stability testing;
Section 211.167--Special testing requirements;
Section 211.180(f)--Notification of responsible officials
of investigations, recalls, reports of inspectional observations, and
any regulatory actions relating to good manufacturing practice;
Section 211.198(a)--Written and oral complaint procedures,
including quality control unit review of any complaint involving
specifications failures, and serious and unexpected adverse drug
experiences;
Section 211.204--Holding, testing, and reprocessing of
returned drug products; and
Section 211.208--Drug product salvaging.
In addition, the following regulations in parts 610 and 680 (21 CFR
parts 610 and 680) reference certain CGMP regulations in part 211:
Sec. Sec. 610.12(g),
[[Page 58814]]
610.13(a)(2), 610.18(d), 680.2(f), and 680.3(f). In table 1, the burden
associated with the information collection requirements in these
regulations is included in the burden estimates under Sec. Sec.
211.165, 211.167, 211.188, and 211.194, as appropriate.
Although most CGMP provisions covered in this document were created
many years ago, some existing firms expanding into new manufacturing
areas and startup firms will need to create SOPs. As provided in table
1, FDA assumes approximately 50 firms will have to create up to 25 SOPs
for a total of 1,250 records, estimating 20 hours per recordkeeper to
create 25 new SOPs for a total of 25,000 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section/activity recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours) \1\
----------------------------------------------------------------------------------------------------------------
SOP Maintenance................. 3,270 .............. 3,270 25 81,750
New Startup SOPs................ 50 25 1,250 20 25,000
211.34--Consultants............. 3,270 0.25 818 5 4090
211.67(c)--Equipment cleaning 3,270 50 163,500 0.25 40,875
and maintenance................
211.68--Changes in master 3,270 2 6,540 1 6,540
production and control records
or other records...............
211.68(a)--Automatic, 3,270 10 32,700 0.5 16,350
mechanical, and electronic
equipment......................
211.68(b)--Computer or related 3,270 5 16,350 0.25 4,088
systems........................
211.72--Filters................. 416 0.25 104 1 104
211.80(d)--Components and drug 3,270 0.25 818 0.1 82
product containers or closures.
211.100(b)--Production and 3,270 3 9,810 2 19,620
process controls...............
211.105(b)--Equipment 3,270 0.25 818 0.25 205
identification.................
211.122(c)--Labeling and 3,270 50 163,500 0.25 40,875
packaging material.............
211.130(e)--Labeling and 3,270 50 163,500 0.25 40,875
packaging facilities...........
211.132(c)--Tamper-evident 1,613 20 32,260 0.5 16,130
packaging......................
211.132(d)--Tamper-evident 1,613 0.2 323 0.5 162
packaging......................
211.137--Expiration dating...... 3,270 5 16,350 0.5 8,175
211.160(a)--Laboratory controls. 3,270 2 6,540 1 6,540
211.165(e)--Test methodology.... 3,270 1 3,270 1 3,270
211.166--Stability testing...... 3,270 2 6,540 0.5 3,270
211.173--Laboratory animals..... 33 1 33 0.25 8
211.180(e)--Production, control, 3,270 0.2 654 0.25 164
and distribution records.......
211.180(f)--Procedures for 3,270 0.2 654 1 654
notification of regulatory
actions........................
211.182--Equipment cleaning and 3,270 2 6,540 0.25 1,635
use log........................
211.184--Component, drug product 3,270 3 9,810 0.5 4,905
container, closure, and
labeling records...............
211.186--Master production and 3,270 10 32,700 2 65,400
control records................
211.188--Batch production and 3,270 25 81,750 2 163,500
control records................
211.192--Discrepancies in drug 3,270 2 6,540 1 6,540
product production and control
records........................
211.194--Laboratory records..... 3,270 25 81,750 0.5 40,875
211.196--Distribution records... 3,270 25 81,750 0.25 20,438
211.198--Compliant files........ 3,270 5 16,350 1 16,350
211.204--Returned drug products. 3,270 10 32,700 0.5 16,350
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 651,139
----------------------------------------------------------------------------------------------------------------
\1\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
minutes per response]/60''.
The recordkeeping requirement estimates provided in table 2 are
specific to medical gases. In particular, on June 29, 2017, FDA
published a Notice of Availability (NOA) in the Federal Register
regarding revised draft guidance for industry entitled ``Current Good
Manufacturing Practice for Medical Gases'' (82 FR 29565). This guidance
is intended to help medical gas manufacturers comply with applicable
CGMP regulations found in parts 210 and 211. In the NOA for the revised
draft guidance, FDA noted the guidance includes information collection
provisions subject to review by the OMB under the PRA and, in
accordance with the PRA, before publication of the final guidance, FDA
intends to solicit public comment and obtain OMB approval for any
recommended new information collections or material modifications to
previously approved collections of information found in FDA
regulations. This notice is intended to solicit such public comment.
The regulations addressed in table 2 are the same as those listed
in table 1, but the estimated information collection burden differs and
is specific to medical gas manufacturing. FDA estimates the burden of
this collection of information as follows:
[[Page 58815]]
Table 2--Estimated Annual Recordkeeping Burden (Medical Gases) \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section/activity recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours) \1\
----------------------------------------------------------------------------------------------------------------
SOP Maintenance................. 2,284 0.65 1,485 25 37,125
New startup SOPs................ 100 25 2,500 20 50,000
211.34--Consultants............. 2,284 0.25 571 0.5 286
211.67(c)--Equipment cleaning 2,284 32.5 74,230 0.25 18,558
and maintenance................
211.68--Changes in master 2,284 2 4,568 1 4,568
production and control records
or other records...............
211.68(a)--Automatic, 2,284 10 22,840 0.5 11,420
mechanical, and electronic
equipment......................
211.68(b)--Computer or related 2,284 5 11,420 0.25 2,855
systems........................
211.72--Filters................. 2,284 0.25 571 1 571
211.80(d)--Components and drug 2,284 0.25 571 0.1 57
product containers or closures.
211.100(b)--Production and 2,284 3 6,382 2 13,704
process controls...............
211.105(b)--Equipment 2,284 0.25 571 0.25 143
identification.................
211.122(c)--Labeling and 2,284 50 114,200 0.25 28,550
packaging material.............
211.130(e)--Labeling and 2,284 50 114,200 0.25 28,550
packaging facilities...........
211.132(c)--Tamper-evident 2,284 20 45,680 0.5 22,840
packaging......................
211.132(d)--Tamper-evident 2,284 0.2 457 0.5 229
packaging......................
211.137--Expiration dating...... 2,284 3.25 7,423 0.33 2,450
211.160(a)--Laboratory controls. 2,284 2 4,568 1 4,568
211.165(e)--Test methodology.... 2,284 1 2,284 1 2,284
211.166--Stability testing...... 2,284 1.3 2,969 0.33 980
211.173--Laboratory animals..... 2,284 1 2,284 0.25 571
211.180(e)--Production, control, 2,284 0.2 457 0.25 114
and distribution records.......
211.180(f)--Procedures for 2,284 0.2 457 1 457
notification of regulatory
actions........................
211.182--Equipment cleaning and 2,284 1.3 2,969 0.16 475
use log........................
211.184--Component, drug product 2,284 1.95 4,454 0.33 1,470
container, closure, and
labeling records...............
211.186--Master production and 2,284 10 22,840 2 45,680
control records................
211.188--Batch production and 2,284 16.25 37,115 1.3 48,250
control records................
211.192--Discrepancies in drug 2,284 2 4,568 1 4,568
product production and control
records........................
211.194--Laboratory records..... 2,284 25 57,100 0.5 28,550
211.196--Distribution records... 2,284 25 57,100 0.25 14,275
211.198--Complaint files........ 2,284 5 11,420 1 11,420
211.204--Returned drug products. 2,284 10 22,840 0.5 11,420
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 396,988
----------------------------------------------------------------------------------------------------------------
\1\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
minutes per response]/60''.
Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26932 Filed 12-13-17; 8:45 am]
BILLING CODE 4164-01-P