0119 GLPs SSA 2017 Extension

FOOD AND DRUG ADMINISTRATION
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
OMB Control No. 0910-0119
SUPPORTING STATEMENT Part A: Justification

1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) regulations.
Specifically, sections 409, 505, 512, and 515 of the Federal Food, Drug, and Cosmetic Act
(FFDCA or the act)(21 U.S.C. 348, 355, 360(b), 360(e)) 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.
Accordingly, we are requesting OMB approval of the information collection provisions
associated with FDA’s GLP regulations codified at 21 CFR Part 58 and discussed in this
supporting statement.

2. Purpose and Use of the Information Collection
FDA evaluates recordkeeping associated with nonclinical laboratory studies 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.
Description of Respondents: Respondents to the collection are contract laboratories, sponsors
of FDA-regulated products, universities, or government agencies. Respondents are from the
private sector (for-profit businesses), as well as state governments and the Federal
government.
3. Use of Improved Information Technology and Burden Reduction
The underlying regulations do not specifically prescribe the use of automated, electronic,
mechanical, or other technological techniques or other forms of information technology as
necessary for use by firms. Companies are free to use whatever forms of information
technology may best assist them in retaining the appropriate records and making them
available to regulatory officials. We estimate that about ninety-five percent (95%) of
respondents will keep some of the required records electronically over the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
We estimate that approximately half of the 300 respondents, or 150, are small businesses.
There are no exemptions to the underlying regulations. However, we believe the reporting
and recordkeeping requirements impose minimal burden on respondents while at the same
time protect the public health by ensuring the quality and integrity of studies conducted in
accordance with the regulations. FDA aids small businesses in complying with its
requirements through our Regional Small Business Representatives and through the scientific
and administrative staffs within the agency. FDA has provided a Small Business Guide on
the agency’s website at
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with the statutory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The information collection is consistent with 5 CFR §1320.5, excepting a 5-year retention
requirement for records relating to toxicology studies supporting investigational new drug

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applications (INDs) or applications for investigational device exemptions (IDEs). Because
the application process under these regulations is approximately a 5-year process, records
must be available to FDA for verification.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), on April 25, 2017 (82 FR 19054), a 60-day notice for
public comment was published in the Federal Register. No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are made to respondents.
10. Assurance of Confidentiality Provided to Respondents
Confidential commercial information is protected from disclosure under section 301(j) of the
act. Additionally, to the extent 21 CFR 20.64 applies, we will honor the confidentiality of any
data in investigation records compiled for law enforcement purposes. All records and reports
maintained by FDA are kept in secured, limited access areas.
11. Justification for Sensitive Questions
The information collection does not contain questions pertaining to sex, behavior, attitude,
religious beliefs, or any matters that are commonly considered private or sensitive in nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1 – Estimated Annual Reporting Burden1
21 CFR Section

58.35(b)(7); Quality
assurance unit
58.185; Reporting of
nonclinical laboratory
study results
TOTAL

No. of
Respondents

No. of
Total Annual
Average
Total
Responses per
Responses
Burden per Hours
Respondent
Response
300
60.25
18,075
1
18,075
300

60.25

18,075

27.65

499,774

517,849

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There are no capital costs or operating and maintenance costs associated with this collection of information.

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Table 2 – Estimated Annual Recordkeeping Burden1
21 CFR Section

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Avg. Burden
per
Recordkeeping

.21
(13 min.)
3.36

Total
Hours

58.29(b); Personnel

300

20

6,000

1,260

58.35(b)(1)-(6), and (c);
Quality assurance unit
58.63(b) and (c);
Maintenance and
calibration of equipment
58.81(a)-(c); SOPs

300

270.76

81,228

300

60

18,000

.09
(5 min.)

1,620

300

301.80

90,540

12,676

58.90(c) and (g); Animal
care
58.105(a) and (b); Test
and control article
characterization
58.107(d); Test and
control article handling
58.113(a); Mixtures of
articles with carriers
58.120; Protocol

300

62.7

18,810

300

5

1,500

.14
(8 min.)
.13
(8 min.)
11.8

17,700

300

1

300

4.25

1,275

300

15.33

4,599

6.8

31,273

300

15.38

4,614

32.7

150,878

58.195; Retention of
records
TOTAL

300

251.50

75,450

3.9

294,255

272,926

2,445

786,308

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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.
12b. Annualized Cost Burden Estimate
The annual hourly burden for the information collection requirements in these regulations is
estimated at 1,304,157 burden hours. The cost to the respondents is estimated by assuming a
cost of $44.91 per hour for 1,304,157 burden hours for a total cost of $58,569,690.87.
Type of Respondent
Industry Compliance
Officer1

Total Burden
Hours
1,304,157

Hourly Wage Rate
$44.91

1

Total Respondent
Costs
$58,569,690.87

May 2016 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor Statistics and
including 30% for benefits.

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13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
The cost of the information collection is absorbed through existing resource allocations.
15. Explanation for Program Changes or Adjustments
The burden has not changed from the currently approved inventory.
16. Plans for Tabulation and Publication and Project Time Schedule
The reporting requirements contained in this proposal are not statistical in nature and the
records are not published for statistical use.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval to exempt display of the OMB approval date on any documents
associated with this information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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