82 FR 19054 - Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range		19054-19056
FR Document		2017-08304

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 provisions of FDA's good laboratory practice (GLP) regulations for nonclinical laboratory studies.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017)

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19054-19056]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-08304]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0075]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Good Laboratory Practice Regulations for Nonclinical
Studies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 provisions of
FDA's good laboratory practice (GLP) regulations for nonclinical
laboratory studies.

DATES: Submit either electronic or written comments on the collection
of information by June 26, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0075 for ``Good Laboratory Practice Regulations for
Nonclinical Studies.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov/ or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential''

[[Page 19055]]

will not be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Good Laboratory Practice Regulations for Nonclinical Studies--21 CFR
Part 58

OMB Control Number 0910-0119--Extension

Sections 409, 505, 512, and 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348, 355, 360b, and 360e) and related statutes
require manufacturers of food additives, human drugs and biological
products, animal drugs, and medical devices to demonstrate the safety
and utility of their product by submitting applications to FDA for
research or marketing permits. Such applications contain, among other
important items, full reports of all studies done to demonstrate
product safety in man and/or other animals. In order to ensure adequate
quality control for these studies and to provide an adequate degree of
consumer protection, the Agency issued GLP regulations for nonclinical
laboratory studies in part 58 (21 CFR part 58). The regulations specify
minimum standards for the proper conduct of safety testing and contain
sections on facilities, personnel, equipment, standard operating
procedures (SOPs), test and control articles, quality assurance,
protocol and conduct of a safety study, records and reports, and
laboratory disqualification.
Part 58 requires testing facilities engaged in conducting
toxicological studies to retain, and make available to regulatory
officials, records regarding compliance with GLPs. Records are
maintained on file at each testing facility and examined there
periodically by FDA inspectors. The GLP regulations require that, for
each nonclinical laboratory study, a final report be prepared that
documents the results of quality assurance unit inspections, test and
control article characterization, testing of mixtures of test and
control articles with carriers, and an overall interpretation of
nonclinical laboratory studies. The GLP regulations also require
written records pertaining to: (1) Personnel job descriptions and
summaries of training and experience; (2) master schedules, protocols
and amendments thereto, inspection reports, and SOPs; (3) equipment
inspection, maintenance, calibration, and testing records; (4)
documentation of feed and water analyses, and animal treatments; (5)
test article accountability records; and (6) study documentation and
raw data.
Recordkeeping is necessary to document the conduct of nonclinical
laboratory studies of FDA-regulated products to ensure the quality and
integrity of the resulting final study report on which a regulatory
decision may be based. Written SOPs and records of actions taken are
essential for testing facilities to implement GLP's effectively.
Further, they are essential for FDA to be able to determine a testing
facility's compliance with the GLP regulations in part 58.
In a notice of proposed rulemaking published in the Federal
Register of August 24, 2016 (81 FR 58342), we proposed changes in our
GLP regulations, including some of those listed in tables 1 and 2 of
this document. The document included revised burden estimates for the
proposed changes and solicited public comment. In response to requests,
the comment period was extended to January 21, 2017 (81 FR 75351,
October 31, 2016). In the interim, FDA is seeking an extension of OMB
approval for the current regulations so that we can continue to collect
information while the proposal is pending.
Description of Respondents: The likely respondents collecting this
information are contract laboratories, sponsors of FDA-regulated
products, universities, or government agencies.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
58.35(b)(7); Quality assurance 300 60.25 18,075 1 18,075
unit...........................
58.185; Reporting of nonclinical 300 60.25 18,075 27.65 499,774
laboratory study results.......
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[[Page 19056]]

Total....................... .............. .............. .............. .............. 517,849
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\1\ There are no capital costs or operating maintenance costs associated with this collection of information.

Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR Section recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
58.29(b); Personnel........... 300 20 6,000 0.21 (13 1,260
minutes).
58.35(b)(1)-(6), and (c); 300 270.76 81,228 3.36............ 272,926
Quality assurance unit.
58.63(b) and (c); Maintenance 300 60 18,000 0.09 (5 minutes) 1,620
and calibration of equipment.
58.81(a)-(c); SOPs............ 300 301.8 90,540 0.14 (8 minutes) 12,676
58.90(c) and (g); Animal care. 300 62.7 18,810 0.13 (8 minutes) 2,445
58.105(a) and (b); Test and 300 5 1,500 11.8............ 17,700
control article
characterization.
58.107(d); Test and control 300 1 300 4.25............ 1,275
article handling.
58.113(a); Mixtures of 300 15.33 4,599 6.8............. 31,273
articles with carriers.
58.120; Protocol.............. 300 15.38 4,614 32.7............ 150,878
58.195; Retention of records.. 300 251.5 75,450 3.9............. 294,255
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Total..................... .............. .............. .............. ................ 786,308
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

The annual burden for the information collection requirements in
these regulations is estimated at 1,304,157 burden hours (517,849 plus
786,308 equals 1,304,157). The hours per response estimates are based
on our experience with similar programs and information received from
industry.

Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08304 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P

19056 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

Total .............................................................................. ........................ ........................ ........................ ........................ 517,849
1 There are no capital costs or operating maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR Section records per Total hours
recordkeepers records recordkeeping
recordkeeper (in hours)

58.29(b); Personnel .............................................. 300 20 6,000 0.21 (13 minutes) ......... 1,260
58.35(b)(1)–(6), and (c); Quality assurance unit .. 300 270.76 81,228 3.36 ............................... 272,926
58.63(b) and (c); Maintenance and calibration of 300 60 18,000 0.09 (5 minutes) ........... 1,620
equipment.
58.81(a)–(c); SOPs ............................................... 300 301.8 90,540 0.14 (8 minutes) ........... 12,676
58.90(c) and (g); Animal care .............................. 300 62.7 18,810 0.13 (8 minutes) ........... 2,445
58.105(a) and (b); Test and control article char- 300 5 1,500 11.8 ............................... 17,700
acterization.
58.107(d); Test and control article handling ........ 300 1 300 4.25 ............................... 1,275
58.113(a); Mixtures of articles with carriers ......... 300 15.33 4,599 6.8 ................................. 31,273
58.120; Protocol ................................................... 300 15.38 4,614 32.7 ............................... 150,878
58.195; Retention of records ................................ 300 251.5 75,450 3.9 ................................. 294,255

Total ............................................................... ........................ ........................ ........................ ....................................... 786,308
1There are no capital costs or operating and maintenance costs associated with this collection of information.

The annual burden for the the Paperwork Reduction Act of 1995 available for FDA inspection when
information collection requirements in (PRA). requested. These records include:
these regulations is estimated at Written procedures describing the
DATES: Fax written comments on the
1,304,157 burden hours (517,849 plus structure and membership of the IRB
collection of information by May 25,
786,308 equals 1,304,157). The hours and the methods that the IRB will use
2017.
per response estimates are based on our in performing its functions; the research
experience with similar programs and ADDRESSES: To ensure that comments on protocols, informed consent documents,
information received from industry. the information collection are received, progress reports, and reports of injuries
Dated: April 19, 2017. OMB recommends that written to subjects submitted by investigators to
Anna K. Abram,
comments be faxed to the Office of the IRB; minutes of meetings showing
Information and Regulatory Affairs, attendance, votes, and decisions made
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. OMB, Attn: FDA Desk Officer, FAX: by the IRB, the number of votes on each
202–395–7285, or emailed to oira_ decision for, against, and abstaining; the
[FR Doc. 2017–08304 Filed 4–24–17; 8:45 am]
submission@omb.eop.gov. All basis for requiring changes in or
BILLING CODE 4164–01–P
comments should be identified with the disapproving research; records of
OMB control number 0910–0130. Also continuing review activities; copies of
DEPARTMENT OF HEALTH AND include the FDA docket number found all correspondence between
HUMAN SERVICES in brackets in the heading of this investigators and the IRB; statement of
document. significant new findings provided to
Food and Drug Administration FOR FURTHER INFORMATION CONTACT: For subjects of the research; and a list of IRB
[Docket No. FDA–2013–N–1163] specific questions for FDA related to members by name, showing each
this document, contact JonnaLynn member’s earned degrees, representative
Agency Information Collection Capezzuto, Office of Operations, Food capacity, and experience in sufficient
Activities; Submission for Office of and Drug Administration, Three White detail to describe each member’s
Management and Budget Review; Flint North, 10A63, 11601 Landsdown contributions to the IRB’s deliberations;
Comment Request; Institutional St., North Bethesda, MD 20852, 301– and any employment relationship
Review Boards 796–3794. between each member and the IRB’s
SUPPLEMENTARY INFORMATION:
institution. This information is used by
AGENCY: Food and Drug Administration, FDA in conducting audit inspections of
asabaliauskas on DSK3SPTVN1PROD with NOTICES

HHS. Institutional Review Boards—21 CFR IRBs to determine whether IRBs and
ACTION: Notice. 56.115—OMB Control Number 0910– clinical investigators are providing
SUMMARY: The Food and Drug 0130—Extension adequate protections to human subjects
Administration (FDA or we) is When reviewing clinical research participating in clinical research.
announcing that a proposed collection studies regulated by FDA, institutional The recordkeeping requirement
of information has been submitted to the review boards (IRBs) are required to burden is based on the following: The
Office of Management and Budget create and maintain records describing burden for the paragraphs under 21 CFR
(OMB) for review and clearance under their operations, and make the records 56.115 has been considered as one

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Document Created: 2017-04-25 02:18:19
Document Modified: 2017-04-25 02:18:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by June 26, 2017.
Contact		JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
FR Citation		82 FR 19054

82 FR 19054 - Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration