Agency Information Collection Activities; Submission for Office of Management and Budget Review; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, 14861-14865 [2018-07031]
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Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the 2003 GFI entitled
‘‘Exposure-Response Relationships—
Study Design, Data Analysis, and
Regulatory Applications’’ at either
https://www.fda.gov/downloads/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
UCM072109.pdf or https://
www.fda.gov/Drugs/
Guidancecompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: April 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07028 Filed 4–5–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1324]
Science Board to the Food and Drug
Administration Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Science Board to the Food and Drug
Administration. The Science Board
provides advice to the Commissioner of
Food and Drugs and other appropriate
officials on specific, complex scientific
and technical issues important to FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board advises
the Agency on keeping pace with
technical and scientific developments,
including in regulatory science;
provides input into the Agency’s
research agenda; and advises on
upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency sponsored
intramural and extramural scientific
research programs. The meeting will be
open to the public.
DATES: The meeting will be held on
April 23, 2018, from 9 a.m. to 4:30 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503, Section A), Silver Spring, MD
20993. For those unable to attend in
person, the meeting will also be
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SUMMARY:
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webcast. The link for the webcast is
available at https://collaboration.fda.
gov/scienceboard2018/. Answers to
commonly asked questions including
information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver Spring,
MD 20993, 301–796–4769,
rakesh.raghuwanshi@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The Science Board will hear
a report from the Center for Biologics
Evaluation and Research Program
Review Subcommittee; hear about
FDA’s Patient Affairs Initiative; and
discuss how the Agency can leverage its
existing tools and authorities, and work
with stakeholders, to better address the
complex scientific, public health, and
technology challenges it faces today.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 18, 2018. Oral
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14861
presentations from the public will be
scheduled between approximately 3:30
p.m. and 4:30 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 13,
2018. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 16, 2018.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Rakesh
Raghuwanshi at least 7 days in advance
of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07105 Filed 4–5–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0362]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Current Good Manufacturing Practice
Regulations for Finished
Pharmaceuticals
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 7,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0139. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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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 (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
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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
‘‘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
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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.
• 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
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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.
• 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.
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• 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.
• 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
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14863
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 filled 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
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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),
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.
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.
In the Federal Register of December
14, 2017 (82 FR 58811) we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received in response to the notice and
we therefore retain those burden
estimates, which are as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section/activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
(in hours) 1
Total hours
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 .............................................
3,270
50
3,270
3,270
3,270
..........................
25
0.25
50
2
3,270
1,250
818
163,500
6,540
25 .........................................
20 .........................................
5 ...........................................
0.25 (15 minutes) ................
1 ...........................................
81,750
25,000
4,090
40,875
6,540
3,270
3,270
416
3,270
10
5
0.25
0.25
32,700
16,350
104
818
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
1 ...........................................
0.1 (6 minutes) ....................
16,350
4,088
104
82
3,270
3,270
3,270
3,270
1,613
1,613
3,270
3,270
3,270
3,270
33
3,270
3,270
3,270
3,270
3
0.25
50
50
20
0.2
5
2
1
2
1
0.2
0.2
2
3
9,810
818
163,500
163,500
32,260
323
16,350
6,540
3,270
6,540
33
654
654
6,540
9,810
2 ...........................................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
0.5 (30 minutes) ..................
0.5 (30 minutes) ..................
0.5 (30 minutes) ..................
1 ...........................................
1 ...........................................
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
1 ...........................................
0.25 (15 minutes) ................
0.5 (30 minutes) ..................
19,620
205
40,875
40,875
16,130
162
8,175
6,540
3,270
3,270
8
164
654
1,635
4,905
3,270
3,270
3,270
10
25
2
32,700
81,750
6,540
2 ...........................................
2 ...........................................
1 ...........................................
65,400
163,500
6,540
3,270
3,270
3,270
3,270
25
25
5
10
81,750
81,750
16,350
32,700
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
1 ...........................................
0.5 (30 minutes) ..................
40,875
20,438
16,350
16,350
Total .....................................................................................
..........................
..........................
........................
..............................................
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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, when finalized, is intended to
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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
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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
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06APN1
Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
burden differs and is specific to medical
gas manufacturing.
14865
FDA estimates the burden of this
collection of information as follows:
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
Number of
records per
recordkeeper
Total annual
records
Total hours
2,284
100
2,284
2,284
2,284
0.65
25
0.25
32.5
2
1,485
2,500
571
74,230
4,568
25 .........................................
20 .........................................
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
1 ...........................................
37,125
50,000
286
18,558
4,568
2,284
2,284
2,284
2,284
10
5
.25
0.25
22,840
11,420
571
571
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
1 ...........................................
0.1 (6 minutes) ....................
11,420
2,855
571
57
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
2,284
2,284
3
0.25
50
50
20
.2
3.25
2
1
1.3
1
0.2
0.2
1.3
1.95
6,382
571
114,200
114,200
45,680
457
7,423
4,568
2,284
2,969
2,284
457
457
2,969
4,454
2 ...........................................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
0.5 (30 minutes) ..................
0.5 (30 minutes) ..................
0.33 (20 minutes) ................
1 ...........................................
1 ...........................................
0.33 (20 minutes) ................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
1 ...........................................
0.16 (10 minutes) ................
0.33 (20 minutes) ................
13,704
143
28,550
28,550
22,840
229
2,450
4,568
2,284
980
571
114
457
475
1,470
2,284
2,284
2,284
10
16.25
2
22,840
37,115
4,568
2 ...........................................
1.3 ........................................
1 ...........................................
45,680
48,250
4,568
2,284
2,284
2,284
2,284
..........................
25
25
5
10
..........................
57,100
57,100
11,420
22,840
........................
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
1 ...........................................
0.5 (30 minutes) ..................
..............................................
28,550
14,275
11,420
11,420
396,988
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
The information collection reflects an
increase in the number of respondents
that results in a corresponding increase
to the number of annual burden hours.
This is consistent with our experience
with the information collection.
[FR Doc. 2018–07031 Filed 4–5–18; 8:45 am]
HRSA is requesting
nominations to fill vacancies on the
Advisory Commission on Childhood
Vaccines (ACCV). The ACCV was
established by Title XXI of the Public
Health Service Act (the Act), and
advises the Secretary of HHS (the
Secretary) on issues related to
implementation of the National Vaccine
Injury Compensation Program (VICP).
BILLING CODE 4164–01–P
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
Dated: April 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Advisory Commission on Childhood
Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice—Request for
nominations for voting members.
AGENCY:
VerDate Sep<11>2014
19:21 Apr 05, 2018
SUMMARY:
The agency will receive
nominations on a continuous basis.
Health Resources and Services
Administration
daltland on DSKBBV9HB2PROD with NOTICES
Average burden
per recordkeeping
(in hours) 1
Jkt 244001
Submit your nominations to
the Director, Division of Injury
Compensation Programs (DICP),
Healthcare Systems Bureau (HSB),
HRSA, 5600 Fishers Lane, Room
08N146B, Rockville, Maryland 20857.
Submit your electronic nomination
package by email to Ms. Annie Herzog
at AHerzog@hrsa.gov.
Ms.
Annie Herzog, Principal Staff Liaison,
DICP, HSB, HRSA, at (301) 443–6634 or
email at aherzog@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Under the
authorities that established the ACCV,
the Federal Advisory Committee Act of
October 6, 1972, (Pub. L. 92–463) and
section 2119 of the Act, 42 U.S.C.
300aa–19, as added by Public Law 99–
660 and amended, HRSA is requesting
nominations for voting members of the
ACCV.
The ACCV advises the Secretary on
the implementation of the VICP. Other
activities of the ACCV include:
Recommending changes to the Vaccine
Injury Table, at its own initiative or as
the result of the filing of a petition;
advising the Secretary on implementing
section 2127 of the Act regarding the
need for childhood vaccination
products that result in fewer or no
significant adverse reactions; surveying
federal, state, and local programs and
activities related to gathering
information on injuries associated with
the administration of childhood
vaccines, including the adverse reaction
reporting requirements of section
2125(b) of the Act; advising the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06APN1.SGM
06APN1
]]>Agencies
[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14861-14865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0362]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Current Good Manufacturing Practice
Regulations for Finished Pharmaceuticals
AGENCY: Food and Drug Administration, HHS.
[[Page 14862]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 7,
2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0139.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
(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
[[Page 14863]]
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.
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 filled 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
[[Page 14864]]
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), 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.
In the Federal Register of December 14, 2017 (82 FR 58811) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received in response to the
notice and we therefore retain those burden estimates, which are as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of records per Total annual Average burden per recordkeeping (in hours) Total hours
recordkeepers recordkeeper records \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.......................................... 4,090
211.67(c)--Equipment cleaning and 3,270 50 163,500 0.25 (15 minutes).......................... 40,875
maintenance.
211.68--Changes in master production and 3,270 2 6,540 1.......................................... 6,540
control records or other records.
211.68(a)--Automatic, mechanical, and 3,270 10 32,700 0.5 (30 minutes)........................... 16,350
electronic equipment.
211.68(b)--Computer or related systems... 3,270 5 16,350 0.25 (15 minutes).......................... 4,088
211.72--Filters.......................... 416 0.25 104 1.......................................... 104
211.80(d)--Components and drug product 3,270 0.25 818 0.1 (6 minutes)............................ 82
containers or closures.
211.100(b)--Production and process 3,270 3 9,810 2.......................................... 19,620
controls.
211.105(b)--Equipment identification..... 3,270 0.25 818 0.25 (15 minutes).......................... 205
211.122(c)--Labeling and packaging 3,270 50 163,500 0.25 (15 minutes).......................... 40,875
material.
211.130(e)--Labeling and packaging 3,270 50 163,500 0.25 (15 minutes).......................... 40,875
facilities.
211.132(c)--Tamper-evident packaging..... 1,613 20 32,260 0.5 (30 minutes)........................... 16,130
211.132(d)--Tamper-evident packaging..... 1,613 0.2 323 0.5 (30 minutes)........................... 162
211.137--Expiration dating............... 3,270 5 16,350 0.5 (30 minutes)........................... 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 (30 minutes)........................... 3,270
211.173--Laboratory animals.............. 33 1 33 0.25 (15 minutes).......................... 8
211.180(e)--Production, control, and 3,270 0.2 654 0.25 (15 minutes).......................... 164
distribution records.
211.180(f)--Procedures for notification 3,270 0.2 654 1.......................................... 654
of regulatory actions.
211.182--Equipment cleaning and use log.. 3,270 2 6,540 0.25 (15 minutes).......................... 1,635
211.184--Component, drug product 3,270 3 9,810 0.5 (30 minutes)........................... 4,905
container, closure, and labeling records.
211.186--Master production and control 3,270 10 32,700 2.......................................... 65,400
records.
211.188--Batch production and control 3,270 25 81,750 2.......................................... 163,500
records.
211.192--Discrepancies in drug product 3,270 2 6,540 1.......................................... 6,540
production and control records.
211.194--Laboratory records.............. 3,270 25 81,750 0.5 (30 minutes)........................... 40,875
211.196--Distribution records............ 3,270 25 81,750 0.25 (15 minutes).......................... 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 (30 minutes)........................... 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, when finalized, 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
[[Page 14865]]
burden differs and is specific to medical gas manufacturing.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Recordkeeping Burden
[Medical Gases] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of records per Total annual Average burden per recordkeeping (in hours) Total hours
recordkeepers recordkeeper records \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 (30 minutes)........................... 286
211.67(c)--Equipment cleaning and 2,284 32.5 74,230 0.25 (15 minutes).......................... 18,558
maintenance.
211.68--Changes in master production and 2,284 2 4,568 1.......................................... 4,568
control records or other records.
211.68(a)--Automatic, mechanical, and 2,284 10 22,840 0.5 (30 minutes)........................... 11,420
electronic equipment.
211.68(b)--Computer or related systems... 2,284 5 11,420 0.25 (15 minutes).......................... 2,855
211.72--Filters.......................... 2,284 .25 571 1.......................................... 571
211.80(d)--Components and drug product 2,284 0.25 571 0.1 (6 minutes)............................ 57
containers or closures.
211.100(b)--Production and process 2,284 3 6,382 2.......................................... 13,704
controls.
211.105(b)--Equipment identification..... 2,284 0.25 571 0.25 (15 minutes).......................... 143
211.122(c)--Labeling and packaging 2,284 50 114,200 0.25 (15 minutes).......................... 28,550
material.
211.130(e)--Labeling and packaging 2,284 50 114,200 0.25 (15 minutes).......................... 28,550
facilities.
211.132(c)--Tamper-evident packaging..... 2,284 20 45,680 0.5 (30 minutes)........................... 22,840
211.132(d)--Tamper-evident packaging..... 2,284 .2 457 0.5 (30 minutes)........................... 229
211.137--Expiration dating............... 2,284 3.25 7,423 0.33 (20 minutes).......................... 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 (20 minutes).......................... 980
211.173--Laboratory animals.............. 2,284 1 2,284 0.25 (15 minutes).......................... 571
211.180(e)--Production, control, and 2,284 0.2 457 0.25 (15 minutes).......................... 114
distribution records.
211.180(f)--Procedures for notification 2,284 0.2 457 1.......................................... 457
of regulatory actions.
211.182--Equipment cleaning and use log.. 2,284 1.3 2,969 0.16 (10 minutes).......................... 475
211.184--Component, drug product 2,284 1.95 4,454 0.33 (20 minutes).......................... 1,470
container, closure, and labeling records.
211.186--Master production and control 2,284 10 22,840 2.......................................... 45,680
records.
211.188--Batch production and control 2,284 16.25 37,115 1.3........................................ 48,250
records.
211.192--Discrepancies in drug product 2,284 2 4,568 1.......................................... 4,568
production and control records.
211.194--Laboratory records.............. 2,284 25 57,100 0.5 (30 minutes)........................... 28,550
211.196--Distribution records............ 2,284 25 57,100 0.25 (15 minutes).......................... 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 (30 minutes)........................... 11,420
Total................................ ............... ............... .............. ........................................... 396,988
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\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 information collection reflects an increase in the number of
respondents that results in a corresponding increase to the number of
annual burden hours. This is consistent with our experience with the
information collection.
Dated: April 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07031 Filed 4-5-18; 8:45 am]
BILLING CODE 4164-01-P
