82 FR 60203 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 242 (December 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 242 (December 19, 2017)
| Page Range | 60203-60204 | |
| FR Document | 2017-27255 |
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)] [Notices] [Pages 60203-60204] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27255] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0075] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies AGENCY: Food and Drug Administration, HHS. 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 January 18, 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 0910-0119. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. 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 good laboratory practice (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 GLPs 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 [[Page 60204]] 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. In the Federal Register of April 25, 2017 (82 FR 19054), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received no comments. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section/activity Number of responses per Total annual Average burden Total hours respondents respondent responses per 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....... ------------------------------------------------------------------------------- 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section/activity Number of records per Total annual Average burden per recordkeeping (in Total hours recordkeepers recordkeeper records hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- 58.29(b); Personnel......................... 300 20 6,000 .21 (13 minutes).......................... 1,260 58.35(b)(1)-(6), and (c); Quality assurance 300 270.76 81,228 3.36...................................... 272,926 unit. 58.63(b) and (c); Maintenance and 300 60 18,000 .09 (5 minutes)........................... 1,620 calibration of equipment. 58.81(a)-(c); SOPs.......................... 300 301.8 90,540 .14 (8 minutes)........................... 12,676 58.90(c) and (g); Animal care............... 300 62.7 18,810 .13 (8 minutes)........................... 2,445 58.105(a) and (b); Test and control article 300 5 1,500 11.8...................................... 17,700 characterization. 58.107(d); Test and control article handling 300 1 300 4.25...................................... 1,275 58.113(a); Mixtures of articles with 300 15.33 4,599 6.8....................................... 31,273 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 ----------------------------------------------------------------------------------------------------------- Total................................... .............. .............. .............. .......................................... 786,308 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 + 786,308 = 1,304,157). The hours per response estimates are based on our experience with similar programs and information received from industry. Dated: December 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27255 Filed 12-18-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices 60203
methods for demonstrating OINDP DEPARTMENT OF HEALTH AND research or marketing permits. Such
therapeutic equivalence. HUMAN SERVICES applications contain, among other
Registration: Persons interested in important items, full reports of all
Food and Drug Administration studies done to demonstrate product
attending this public workshop must
[Docket No. FDA–2011–N–0075] safety in man and/or other animals. In
register online by December 30, 2017, by
order to ensure adequate quality control
going to https://www.fda.gov/Drugs/
Agency Information Collection for these studies and to provide an
NewsEvents/ucm576064.htm. Please adequate degree of consumer protection,
provide complete contact information Activities; Submission for Office of
Management and Budget Review; the Agency issued good laboratory
for each attendee, including name, title, practice (GLP) regulations for
Comment Request; Good Laboratory
affiliation, address, email, and nonclinical laboratory studies in part 58
Practice Regulations for Nonclinical
telephone. The workshop agenda and (21 CFR part 58). The regulations
Studies
other background materials will be specify minimum standards for the
available approximately 2 weeks before AGENCY: Food and Drug Administration, proper conduct of safety testing and
the workshop at https://www.fda.gov/ HHS. contain sections on facilities, personnel,
Drugs/NewsEvents/ucm576064.htm. ACTION: Notice. equipment, standard operating
The agenda will include time for procedures (SOPs), test and control
questions and answers throughout the SUMMARY: The Food and Drug articles, quality assurance, protocol and
day and for general comments and Administration (FDA) is announcing conduct of a safety study, records and
questions from the audience following that a proposed collection of reports, and laboratory disqualification.
panel discussions. information has been submitted to the Part 58 requires testing facilities
Office of Management and Budget engaged in conducting toxicological
Registration is free and based on (OMB) for review and clearance under studies to retain, and make available to
space availability, with priority given to the Paperwork Reduction Act of 1995. regulatory officials, records regarding
early registrants. Persons interested in DATES: Fax written comments on the compliance with GLPs. Records are
attending this public workshop must collection of information by January 18, maintained on file at each testing
register by December 30, 2017, midnight 2018. facility and examined there periodically
Eastern Time. Early registration is by FDA inspectors. The GLP regulations
ADDRESSES: To ensure that comments on
recommended because seating is the information collection are received, require that, for each nonclinical
limited; therefore, FDA may limit the OMB recommends that written laboratory study, a final report be
number of participants from each comments be faxed to the Office of prepared that documents the results of
organization. If time and space permit, Information and Regulatory Affairs, quality assurance unit inspections, test
onsite registration on the day of the OMB, Attn: FDA Desk Officer, Fax: 202– and control article characterization,
public workshop will be provided 395–7285, or emailed to oira_ testing of mixtures of test and control
beginning at 8:30 a.m. submission@omb.eop.gov. All articles with carriers, and an overall
comments should be identified with the interpretation of nonclinical laboratory
If you need special accommodations studies. The GLP regulations also
due to a disability, please contact OMB control number 0910–0119. Also
require written records pertaining to: (1)
Renishkumar Delvadia no later than include the FDA docket number found
Personnel job descriptions and
December 30, 2017. in brackets in the heading of this
summaries of training and experience;
document.
Streaming Webcast of the public (2) master schedules, protocols and
workshop: This public workshop will FOR FURTHER INFORMATION CONTACT: Ila amendments thereto, inspection reports,
also be webcast. A live webcast of this S. Mizrachi, Office of Operations, Food and SOPs; (3) equipment inspection,
workshop will be viewable at https:// and Drug Administration, Three White maintenance, calibration, and testing
collaboration.fda.gov/r19djs3yfsf/ on Flint North, 10A–12M, 11601 records; (4) documentation of feed and
the day of the workshop. A video record Landsdown St., North Bethesda, MD water analyses, and animal treatments;
of the workshop will be available at the 20852, 301–796–7726, PRAStaff@ (5) test article accountability records;
fda.hhs.gov. and (6) study documentation and raw
same web address for 1 year. If you have
SUPPLEMENTARY INFORMATION: In data.
never attended a Connect Pro event Recordkeeping is necessary to
before, test your connection at https:// compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed document the conduct of nonclinical
collaboration.fda.gov/common/help/en/ laboratory studies of FDA-regulated
support/meeting_test.htm. To get a collection of information to OMB for
products to ensure the quality and
quick overview of the Connect Pro review and clearance.
integrity of the resulting final study
program, visit https://www.adobe.com/ Good Laboratory Practice Regulations report on which a regulatory decision
go/connectpro_overview. FDA has for Nonclinical Studies—21 CFR Part may be based. Written SOPs and records
verified the website addresses in this 58 of actions taken are essential for testing
document, as of the date this document facilities to implement GLPs effectively.
OMB Control Number 0910–0119—
publishes in the Federal Register, but Further, they are essential for FDA to be
Extension
websites are subject to change over time. able to determine a testing facility’s
Sections 409, 505, 512, and 515 of the compliance with the GLP regulations in
Dated: December 13, 2017.
Federal Food, Drug, and Cosmetic Act
sradovich on DSK3GMQ082PROD with NOTICES
part 58.
Leslie Kux, (21 U.S.C. 348, 355, 360b, and 360e) and In a notice of proposed rulemaking
Associate Commissioner for Policy. related statutes require manufacturers of published in the Federal Register of
[FR Doc. 2017–27279 Filed 12–18–17; 8:45 am] food additives, human drugs and August 24, 2016 (81 FR 58342), we
BILLING CODE 4164–01–P biological products, animal drugs, and proposed changes in our GLP
medical devices to demonstrate the regulations, including some of those
safety and utility of their product by listed in tables 1 and 2 of this
submitting applications to FDA for document. The document included
VerDate Sep<11>2014 17:47 Dec 18, 2017 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\19DEN1.SGM 19DEN1](https://thefederalregister.org/doc/82_FR_60445/page/1.svg)
![60204 Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices
revised burden estimates for the current regulations so that we can In the Federal Register of April 25,
proposed changes and solicited public continue to collect information while 2017 (82 FR 19054), FDA published a
comment. In response to requests, the the proposal is pending. 60-day notice requesting public
comment period was extended to Description of Respondents: The comment on the proposed collection of
January 21, 2017 (81 FR 75351, October likely respondents collecting this information. We received no comments.
31, 2016). In the interim, FDA is seeking information are contract laboratories,
sponsors of FDA-regulated products, FDA estimates the burden of this
an extension of OMB approval for the collection of information as follows:
universities, or government agencies.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section/activity responses per burden per Total hours
respondents responses
respondent response
58.35(b)(7); Quality assurance unit ..................................... 300 60.25 18,075 1 18,075
58.185; Reporting of nonclinical laboratory study results ... 300 60.25 18,075 27.65 499,774
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
Number of Average burden
Number of Total annual
21 CFR section/activity records per per recordkeeping Total hours
recordkeepers records
recordkeeper (in hours)
58.29(b); Personnel ................................................. 300 20 6,000 .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 .09 (5 minutes) .......... 1,620
equipment.
58.81(a)–(c); SOPs .................................................. 300 301.8 90,540 .14 (8 minutes) .......... 12,676
58.90(c) and (g); Animal care .................................. 300 62.7 18,810 .13 (8 minutes) .......... 2,445
58.105(a) and (b); Test and control article charac- 300 5 1,500 11.8 ........................... 17,700
terization.
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
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The annual burden for the DEPARTMENT OF HEALTH AND recognizes the value of standards and
information collection requirements in HUMAN SERVICES encourages the use of appropriate
these regulations is estimated at standards to facilitate the evaluation of
1,304,157 burden hours (517,849 + Food and Drug Administration products regulated by the Center for
786,308 = 1,304,157). The hours per Biologics Evaluation and Research
[Docket No. FDA–2017–D–6535] (CBER). The guidance describes CBER’s
response estimates are based on our
experience with similar programs and recommendations on the use of
Standards Development and the Use of standards in product development and
information received from industry. Standards in Regulatory Submissions the use of such standards in CBER’s
Dated: December 13, 2017. Reviewed in the Center for Biologics managed review process. The draft
Leslie Kux, Evaluation and Research; Draft guidance does not endorse the activities
Guidance for Industry and Food and of specific Standards Development
Associate Commissioner for Policy.
Drug Administration Staff; Availability Organizations or recommend specific
[FR Doc. 2017–27255 Filed 12–18–17; 8:45 am]
BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, standards for use in regulatory
HHS. submissions.
ACTION: Notice of availability. DATES: Submit either electronic or
written comments on the draft guidance
SUMMARY: The Food and Drug by March 19, 2018 to ensure that the
Administration (FDA or Agency) is Agency considers your comment on this
announcing the availability of a draft
sradovich on DSK3GMQ082PROD with NOTICES
draft guidance before it begins work on
document entitled ‘‘Standards the final version of the guidance.
Development and the Use of Standards ADDRESSES: You may submit comments
in Regulatory Submissions Reviewed in on any guidance at any time as follows:
the Center for Biologics Evaluation and
Research; Draft Guidance for Industry Electronic Submissions
and Food and Drug Administration Submit electronic comments in the
Staff.’’ The draft guidance document following way:
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Document Created: 2017-12-19 01:31:32
Document Modified: 2017-12-19 01:31:32
| 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 | Fax written comments on the collection of information by January 18, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 60203 |
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