0119 Supporting Statement for GLP PR published 24 Aug 2016

Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
OMB Control No. 0910-0119
SUPPORTING STATEMENT Part A
A. Justification
1. Circumstances Making the Collection of Information Necessary
Sections 402, 406, 408, 409, 501, 502, 503, 505, 510, 512-516, 518-520, 571, 701, 721, 801,
905, 910, and 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and sections 351
and 354-360F of the Public Health Service Act require sponsors or manufacturers of certain
Food and Drug Administration (FDA)-regulated products (e.g., food and color additives, animal
food additives, human and animal drugs, devices, biological products, electronic products, and
tobacco products) to demonstrate the safety and effectiveness of their product in applications or
submissions to FDA prior to marketing those products or prior to allowing certain products into
clinical studies. Such applications and submissions contain, among other important items, full
reports of all nonclinical laboratory studies done to demonstrate product safety in man and/or
other animals. In order to ensure the quality and integrity of the data from these nonclinical
laboratory studies, the agency issued good laboratory practice (GLP) regulations for nonclinical
laboratory studies in part 58 (21 CFR part 58).
In the Federal Register of August 24, 2017 (81 FR 58342) FDA published a proposed rule to
amend the GLP regulations in part 58 to require a complete quality system approach, referred to
as a GLP Quality System, when safety and toxicity studies support or are intended to support
applications or submissions for products regulated by FDA. If finalized, the rule will expand the
scope of the GLP regulation to include all products for which nonclinical laboratory studies are
currently conducted that are not explicitly discussed in the current regulation, specifically
tobacco products. The proposed expanded scope also includes all applications and submissions
under the FD&C Act that can be supported by the results of nonclinical laboratory studies.
As discussed in the proposed rule, provisions for reporting and recordkeeping presently
required by 21 CFR part 58, Good Laboratory Practice for Nonclinical Laboratory Studies would
be revised to support the new regulatory requirements. Accordingly, FDA is requesting OMB
approval for the information collection provisions associated with its proposed rule.
2. Purpose and Use of the Information Collection
Results of nonclinical laboratory studies may be submitted in support of applications and
submissions to FDA by persons desiring to market new products or research such products in
clinical studies. The information submitted to FDA surrounding a nonclinical laboratory study,
such as the final study report, gives FDA’s scientific review experts the information needed to
help determine the safety or toxicity of the test article or both. FDA uses such safety and toxicity
information to make regulatory decisions regarding the test article, including permitting the
conduct of clinical studies on human subjects, determining safe levels of residual drug for drugs

administered to animals whose products will be consumed by humans, and marketing new
products for both human and non-human animal use.
FDA’s regulations in part 58 require testing facilities engaged in conducting nonclinical
laboratory studies to retain, and make available to regulatory officials, records regarding
compliance with good laboratory practices. 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. FDA
conducts on-site reviews of records and reports during inspections of persons conducting one or
more nonclinical laboratory study phases and uses the information to verify the reliability of
results submitted in support of applications and submissions to FDA.
3. Use of Improved Information Technology and Burden Reduction
FDA estimates that 90% of the respondents will use electronic means to fulfill the agency’s
requirement or request. FDA, as an agency, is aware of the dramatic cost improvements possible
through computerization and is actively encouraging electronic recordkeeping and electronic
submission of new product applications. FDA is proposing to update part 58 to help address the
use of present technology. Currently, some provisions, which were written prior to the
widespread use of electronic media, require persons conducting nonclinical laboratory studies to
maintain paper records, requirements that hamper the efficient use of resources. However, this
proposal would modernize our regulations to allow for the acceptance of electronic records
rather than requiring paper records. In addition, we propose eliminating any current
requirements that might impede a fully computerized facility.
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
As discussed in the Preliminary Regulatory Impact Analysis (PRIA), the Small Business
Administration (SBA) uses different definitions of small entity for different industries. Based on
SBA size standards, except for blood and organ banks whose size is determined based on
revenues, most firms covered by the proposed rule would be considered small if they employ
fewer than 500 employees. Firms in the tobacco industry would be considered small if they
employ fewer than 1000 employees. Firms in the pharmaceutical industry are considered small
if they employ fewer than 750 employees. Blood and organ banks would be considered small if
their annual revenue is less than $10 million.
Currently available data from the 2007 Economic Census show that at least 92 percent of the
establishments in pharmaceutical, medical devices, foods, and biologics (except blood and blood
organs) industries would be considered small by SBA standards. Our Registration and Listing
data indicate that 15 (12.7 percent) of the registered tobacco manufacturers are considered small.
Using revenue measures as determined by the SBA standards we estimate that 72 percent of
blood and organ banks would be considered small. The proposed procedures are no more

2

burdensome for small businesses than for large. The proposed recordkeeping requirements are
the minimum requirements to ensure documentation of the conduct and data collection of
nonclinical laboratory studies of FDA-regulated products and thus ensure the quality and
integrity of the resulting final study report. The proposed regulations provide flexibility to
entities involved in the conduct of nonclinical laboratory studies, including the sponsor, testing
facility, and any contracted persons. This provides the necessary flexibility to accommodate the
various methods and capabilities of both large and small entities. FDA aids small businesses in
complying with its requirements through the agency’s 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
Information collection schedule is consistant with regulatory requirements and requires
reporting only on an occasional basis. We believe this imposes minimal burden on respondents
while at the same time preserving data quality of information submitted to the agency.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The subject information collection requirements are consistent with 5 CFR §1320.5 with the
exception of the 5-year retention of records related to nonclinical laboratory studies supporting
investigational new drug applications (INDs) or applications for investigational device
exemptions (IDEs). This extended retention period is necessary because it is approximately a 5year process. These records must be available to FDA inspectors so they can be examined
during on-site visits to verify the quality and integrity of the data.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
As required by section 3506(c)(2)(B) of the Paperwork Reduction Act of 1995 (PRA), FDA
provided an opportunity for public comment on the information collection requirements of the
proposed rule that published in the Federal Register on August 24, 2016 (81 FR ).
In addition, FDA published an advanced notice of proposed rulemaking entitled, “Good
Laboratory Practice for Nonclinical Laboratory Studies” (75 FR 80011, December 21, 2010), to
solicit stakeholder input regarding FDA’s intention to modify the GLP regulations in part 58.
All comments were reviewed and considered by a working group with representatives from all
FDA Centers, along with representatives from the U.S. Environmental Protection Agency (EPA),
the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture
(USDA/APHIS), and the Office of Laboratory Animal Welfare at the National Institutes of
Health (NIH/OLAW).
Finally, FDA has extensive contacts and consults with the affected industry, other
government agencies, and international organizations which have an interest in the

3

implementation of the GLP regulations. The regulations have been revised four times since their
inception in 1978, to refine and improve their application. These consulting efforts continue.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payment or gift to respondents.
10. Assurance of Confidentiality Provided to Respondents
Information submitted to FDA may contain trade secret and confidential commercial
information. In addition, the agency expects that it may inspect firm records containing
confidential commercial information. Only information that is releasable under the agency’s
regulations in 21 CFR part 20 would be released to the public. This information is also
safeguarded by Section 301(j) of the FD&C Act and would be protected from disclosure under
the Freedom of Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)).
To the extent 21 CFR 20.64 applies, FDA 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 limited access areas.
11. Justification for Sensitive Questions
The information collection does not contain questions of a sensitive 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:
Description of respondents: Respondents to the information collection are persons
conducting a phase of a nonclinical laboratory study that is within the proposed expanded scope
of part 58, including their personnel, independent contributing scientists, and study sponsors as
the latter two terms are defined in this proposed rule; universities; or government agencies.
Reporting:
Currently, the GLP regulations include: (1) Report the results of QAU inspections; (2) submit
periodic QAU study reports; (3) provide a QAU statement as part of the final study report; (4)
provide the results of test and control article characterization and the testing of mixtures of test
and control articles with carriers; (5) report a change in archive location; and (6) prepare in
writing a final study report containing an overall interpretation of nonclinical laboratory studies.

4

The proposed rule will revise these requirements to include (1) a final study report
incorporating additional information about all persons conducting one or more nonclinical
laboratory study phases and a study director’s compliance statement; (2) QAU reports on
facility-based inspections and process-based inspections, where conducted; (3) written
certification whenever a process-based QAU inspection reveals problems, with documentation
that records the actions taken; (4) summaries of the close-out of discontinued studies; (5)
notification of the change of archival site within a specified timeframe; (6) reports by the study
sponsor to the study director of known risks of the test article and necessary measures to protect
study personnel; and (7) reports by the study sponsor to the study director of the results of
characterization of any reference articles that may be employed in a study as well of mixtures of
such reference articles with carriers. Finally, for sponsors who submit the results of nonclinical
laboratory studies in support of applications or submissions to FDA that are proposed additions
to the scope of part 58 and that lack enacting regulations, (8) submission of the final study report
and a GLP compliance statement.
QAU inspection reports provide the study director and management with executive
responsibility information about the progress of a study and its compliance with GLP regulations
so they can take any corrective actions required to ensure the quality and integrity of the data.
Test, control, and reference article information helps ensure proper dosing of the test system(s)
and allows interpretation of study results in the final study report. The study sponsor receives
the final study report and commonly submits the report in support of an application or
submission to FDA. The information in the final study report gives FDA’s scientific review
experts the information needed to help determine the safety or toxicity of the test article or both.
FDA needs such safety and toxicity information to make regulatory decisions regarding the test
article, including permitting the conduct of clinical studies on human subjects, determining safe
levels of residual drug for drugs administered to animals whose products will be consumed by
humans, and marketing new products for both human and non-human animal use. Since a
number of the additional applications and submissions proposed for the scope expansion do not
have enacting regulations, inclusion in part 58 is necessary.
We estimate the reporting burden of this collection of information as follows:
Table 1.—Estimated One-time Reporting Burden1
Activity

No. of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

Avg. Burden
per Response

Total
Hours

Read and Understand the
Proposed Rule: Sponsors of
2,193
1
2,193
7.2
15,790
Nonclinical Laboratory Studies
Read and Understand the
Proposed Rule: Testing Facilities
300
1
300
18
5,400
of Nonclinical Laboratory Studies
Total
2,493
21,190
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 1 shows the estimated one-time burden associated with the new reporting provisions of
the proposed rule. We expect that persons conducting a phase of a nonclinical laboratory study
that is within the proposed expanded scope of part 58 will need to read and understand the

5

proposed rule. We expect that some entities would face lower complexity from reading the
proposed rule and some entities would face higher complexity. In the PRIA, we calculated lower
and upper estimates of time to read and understand the proposed rule under a low-complexity
scenario for sponsors of nonclinical laboratory studies who would face fewer provisions. Our
estimates under a high-complexity scenario apply to testing facilities of nonclinical laboratory
studies that would have to read and understand more provisions in the rule. As stated in the
PRIA, we estimate that there are 2,193 sponsors of nonclinical laboratory studies and 300 testing
facilities of nonclinical laboratory studies. We estimate that the 2,193 sponsors of nonclinical
laboratory studies will take from 4.8 to 9.6 hours, for an average of 7.2 hours, to read and
understand the proposed rule. We expect that the 300 testing facilities of nonclinical laboratory
studies will take from 12 to 24 hours, for an average of 18 hours, to read and understand the
proposed rule.
Table 2 – Estimated Recurring Reporting Burden1
21 CFR Part 58
Proposed new requirements
1

Number of
respondents
300

Number of
responses per
respondent
224.9

Total
annual
responses
67,465

Avg. burden
per response

Total hours

1.03

69,386.25

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

Recordkeeping
Currently, the GLP regulations include requirements that respondents must record: (1)
personnel job descriptions and summaries of training and experience; (2) master schedules,
protocols, and protocol amendments; (3) equipment inspection, maintenance, calibration, and
testing records; (4) SOPs; (5) documentation of feed and water analyses and animal treatments;
(6) test article accountability records; and (7) study documentation, including raw data.
This proposed rule will add to the existing requirements with regard to initial changes and
additions to SOPs for both testing facilities and test sites to develop, implement, and maintain a
GLP Quality System and to expand many SOPs to specifically include multisite studies.
This proposed rule would also expand personnel record maintenance to require records of
training and experience on GLP requirements and species-specific animal care. In addition, this
proposed rule includes revisions to the required content of study protocols as part of a GLP
Quality System and for multisite study specifics.
The additional documentation by management with executive responsibility and study
directors is for the implementation of a GLP Quality System and the resulting additional burden
is nominal. Documentation by independent contributing scientists, as defined in this proposed
rule, includes records these individuals would usually retain, so nominal added burden is
predicted.
To implement the proposed checks and balances discussed in the preamble to the proposed
rule, proposed revisions will require that added documentation be made by study director and
the QAU to ensure the viability of the proposed GLP Quality System (see Table 5).

6

This proposed rule also adds requirements for the study sponsor to maintain records of (1)
protocol and protocol amendment approval; (2) the accreditation status of a contracted person (as
defined in this proposed rule) that conducts a phase of the study that involves the use of animals;
(3) test, control, and reference article characterization; and (4) the qualifications of all contracted
persons.
In addition, the proposed rule includes recordkeeping requirements for nonclinical laboratory
studies that choose to utilize the option of having a principal investigator, particularly for
multisite studies. These individuals will have recordkeeping responsibilities comparable to those
of the study director for the nonclinical laboratory study phases for which they are responsible.
The persons potentially retaining nonclinical laboratory study documents are persons
conducting a phase of a nonclinical laboratory study that is within the proposed expanded scope
of part 58, including independent contributing scientists, and study sponsors as defined in this
proposed rule. Results of nonclinical laboratory studies may be used by firms in support of
applications and submissions to FDA, including applications and submissions for research and
marketing of new products. The additional documentation of the conduct and data collection of
nonclinical laboratory studies of FDA-regulated products will help ensure the quality and
integrity of the final study report. FDA conducts on-site reviews of records and study reports
during inspections of persons conducting one or more nonclinical laboratory study phases to
verify the reliability of results submitted in support of applications and submissions to FDA.
We estimate the recordkeeping burden of this collection of information as follows:
Table 3.—Estimated One-time Recordkeeping Burden1
Activity

No. of
Recordkeepers

No. of
Records per
Recordkeeper
12
10
2

Total Annual
Records

Average Burden
per Recordkeeping

Total Hours

Update Existing SOPs
300
3,600
7.5
27,000
Write New SOPs
300
3,000
24
72,000
Training
300
600
14
8,400
Total
7,200
107,400
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 3 shows the estimated one-time burden associated with the revised recordkeeping
provisions of the proposed rule. We expect that the 300 testing facilities of nonclinical
laboratory studies will need to update existing SOPs and to write new SOPs. In the PRIA, we
estimated that each facility would need to update 12 existing SOPs and write 10 new SOPs. We
calculated lower and upper estimates of time to update existing SOPs and to write new SOPs.
We estimate that it will take from 4 to 11 hours, for an average of 7.5 hours, to update 12
existing SOPs. We estimate that it will take from 15 to 33 hours, for an average of 24 hours, to
write 10 new SOPs. We also expect that the 300 testing facilities of nonclinical laboratory
studies will need to conduct training. In the PRIA, we estimated that for the low estimate one
person would be doing the training and one person would be trained. By contrast, for the high
estimate, we estimated that also one person would be doing the training and potentially three
people would receive such training, for an average of two employees for each facility. We
calculated lower and upper estimates of time to train, estimating that it will take from 5 to 23
hours, for an average of 14 hours, to train.
7

Table 4.—Estimated Recurring Recordkeeping Burden1
No. of
Recordkeepers

21 CFR Section Part 58
Proposed new
requirements
1

300

No. of Records
per
Recordkeeper
20

Total
Annual
Records
1,188,031

Avg. burden
per
recordkeeping

Total Hours
906,289.5

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

With input from the Society for Quality Assurance (SQA) and other experts in the field, we
estimated the number of entities (responders), the annual reporting frequency, and total labor
hours associated with each of the additional proposed requirements.
12b. Annualized Cost Burden Estimate
Reporting Costs
The proposed rule proposes additional reporting responsibilities from various entities
involved in the conduct of a nonclinical laboratory study to enhance the information that is
essential to implement the proposed GLP Quality System, e.g., providing information on test,
control, and reference article characterization, reporting results of process-based inspections, and
adequate reporting of study deviations and study reports. Table 6A below briefly describes the
additional reporting requirements, and the proposed entity responsible for ensuring the
requirement is fulfilled.
Additional Reporting Responsibilities Proposed by the Rule
Main Entity Responsible

Additional Reporting Responsibility
R01. Provide test, control, and reference article characterization and risk
information

Sponsor
R02. Provide nonclinical laboratory study report in support of applications
and submissions
Quality Assurance Unit (QAU)

Management with Executive
Responsibility

R03. Expanded content of QAU statement in final study report
R04. Management report of actions taken when a process-based inspection
reveals problems
R05. Management report of personnel deviations from protocol
R06. Expanded contents of final study report

Study Director

R07. Compliance statement by study director appended to final study report
R08. Summary report of close-out for discontinued studies

Contributing Scientists or
Principal Investigators

R09. Reports by independent contributing scientist(s) to study director or
principal investigator

8

R10. Study deviation reports from principal investigator to study director

R11. Signed and dated compliance statement, final study reports and
amendments, if applicable, from principal investigator to study director
1

Task may involve other assistance such as clerical.

With input from the Society for Quality Assurance (SQA) and other experts in the field, we
estimated the number of entities (responders), the annual reporting frequency, and total labor
hours associated with each of the additional proposed requirements. In estimating the value of
labor resources, we assume 25 percent of the total estimated labor time is allocated to clerical
assistance. We seek comments or data to support other assumptions on this issue.
Because the composition of the entities affected cover manufacturers across all product areas
regulated by FDA, we use the median hourly wage rate for industry sectors 31, 32, and 33 as
reported by the Bureau of Labor Statistics for 2014 (Ref. 1) to value labor hours. Reporting
responsibilities for the sponsor or other entities with a managerial role are valued using
“Management Occupations,” (Standard Occupation Code (SOC), 110000) at $52.80 per hour.
Labor hours for contributing scientists or investigators are valued using an average of the wage
rate for the following occupations “Statisticians” (SOC 152041, hourly wage of $45.71),
“Chemists and Material Scientists” (SOC 192030, hourly wage rate of $35.82), “Veterinarians”
(SOC 291131, hourly wage rate of $34.26), “Biochemists and Biophysicists” (SOC 191021,
hourly wage rate of $40.92), “Environmental Scientists and Specialists including Health” (SOC
192041, hourly wage rate of $41.83), “Biological Scientists” (SOC 191020, hourly wage rate of
$37.44), “Animal Scientists” (SOC 191011, hourly wage rate of $34.46). The average wage rate
among these occupations is $39.90. Clerical assistance is valued using SOC 434071 (“File
Clerks”) reported at $14.42 per hour. Before calculating the estimated labor cost we multiply the
reported wage rate by 2—a commonly used multiplier—to adjust the median hourly wage rate
for benefits and overhead.
Estimated total cost for each of the additional proposed responsibilities is determined by
multiplying the number of entities affected by the annual reporting frequency per entity affected
and the unit labor cost (see Table 6B). Unit cost of labor for each reporting responsibility is
calculated as the labor hours per entity involved in the specific reporting task times the wage
rate. For instance, total cost of $0.57 million for reporting responsibility code R01 (“Provide
test, control, and reference article characterization and risk information”) is calculated as
follows: 1,316 respondents x 5 average annual responses per respondent x (0.75 hours x $105.60
per hour + 0.25 hours x $28.84 per hour). The reporting costs for the remaining reporting
responsibilities, R02-R12, are calculated in a similar fashion. Adding the estimated costs across
all entities affected provides an estimated annual cost of the proposed rule of $5.8 million. We
note that even though Table 6B provides costs disaggregated by entity responsible; these costs
will be mainly paid by the sponsor funding the nonclinical laboratory study.

9

Table 6B.--Estimated Reporting Costs of the Proposed Rule
Labor Hours (per response)
Additional
Reporting
Responsibility

Main Entity
Responsible1

Sponsor
Quality
Assurance Unit
(QAU)
Management
with Executive
Responsibility
Study Director

R01

Number
of Entities
Affected
1316

Average
Annual
Reporting
5

Total
Hours
per
Response
1

R02

10

1

R03
R04

300
10

R05
R06
R07
R08

300
300
300
300

Main
Entity
0.75

Clerical
Assistan
t
0.25

Unit Cost
$86.41

Total
Cost
(millions
)
$0.57

15

11.25

3.75

$1,296.15

$0.01

60.25
2

0.25
5

0.19
3.75

0.06
1.25

$21.60
$432.05

$0.39
$0.01

10
60.25
60.25
2

0.5
2
0.5
2

0.38
1.50
0.38
1.50

0.13
0.50
0.13
0.50

$43.21
$172.82
$43.21
$172.82

$0.13
$3.12
$0.78
$0.10

Independent
R09
30
1
5
3.75
1.25
$335.28
$0.01
Contributing
Scientist or
R10
200
10
1
0.75
0.25
$67.06
$0.13
Principal
Investigator
R11
200
5
8
6.00
2.00
$536.45
$0.54
Total
$5.8
1
Hourly median wage rate for sponsor, QAU, and management with executive responsibility is $105.60, $79.80 for
contributing scientists or principal investigators, and $28.84 for clerical assistants. Total may not add up due to
rounding. See Table 6A for a description of each reporting code. The number of affected entities and additional burden
come from the Paperwork Reduction Act estimates in the preamble.

Recordkeeping Costs
The proposed rule proposes additional recordkeeping responsibilities from multiple entities
involved in the conduct of a nonclinical laboratory study to enhance the information that is
essential for appropriate conduct of nonclinical laboratory studies, e.g., documenting protocol
and SOPs approval, documenting training and inspectional findings. Table 6C below briefly
describes the additional proposed recordkeeping requirements, and the proposed entity
responsible for ensuring each of the additional requirements is fulfilled.
Table 6C.--Additional Recordkeeping Responsibilities Proposed by Rule
Main Entity Responsible1
Additional Documentation Responsibility
K01. Protocol approval, including all amendments
K02. Animal welfare determination
Sponsor

K03. Accreditation status of person conducting the animal testing
K04. Test, control, and reference article parameters
K05. Archival locations
K06. Qualifications of contracted persons

10

K07. Training and experience on GLP
K08. Training and experience on animal care
K09. All persons are qualified for multisite studies
K10. Periodic review of GLP Quality System
Management with executive
responsibility

K11. Periodic review of QAU
K12. Appointment of management representative
K13. All test sites have master schedule
K14. Appointment of person to manage master schedule
K15. Selection of lead QAU for multisite studies
K16. Process-based inspections
K17. Audits of final reports of contributing scientists

Quality Assurance Unit (QAU)

K18. Audits of principal investigator reports
K19. Audits of final study reports for multisite studies
K20. Review of protocols and amendments
K21. Review of SOPs and amendments as they pertain to specific studies
K22. Multisite need for PIs
K23. Document communications
K24. Compliance with protocol
K25. QAU review of protocol and applicable SOPs
K26. Management provided adequate resources

Study Director

K27. Computerized systems validated
K28. Review by animal study review board
K29. Multisite personnel qualified
K30. Test system as required
K31. GLP compliance
K32. Test article accountability when containers disposed of
K33. Education, training, and experience

Independent Contributing Scientist

K34. Archive location
K35. Appropriate animal care (when applicable)
K36. Protocol and protocol amendment acceptance

Principal Investigator

K37. Study deviations
K38. Archive location

1

Task may involve other assistance such as clerical.

To estimate recordkeeping costs we use the same wage rates discussed in section E1 above.
However, we assume that documentation and recordkeeping activities involve 75 percent of the
total labor hours allocated to clerical assistants and 25 percent to the main entity responsible for
the documentation. Thus, after adjusting for benefits and overhead, the hourly wage rate for

11

entities with a managerial role (“Management Occupations,” SOC 110000) is $105.60 and
$28.84 for clerks (“File Clerks,” SOC 434071).
Estimated total cost for each of the additional recordkeeping responsibilities is determined by
multiplying the number of entities affected by the annual recordkeeping frequency per entity
affected and the unit labor cost (for brevity we provide this information in Table A1 of the
Appendix to the PRIA). Unit cost of labor for each recordkeeping responsibility is calculated as
the labor hours per entity involved in the specific task times the wage rate. For instance, total
cost of $10.53 million for responsibility K01, “Protocol approval, including all amendments”, is
calculated as follows: 2,193 respondents x 100 responses per respondent x (0.25 hours x $105.60
per hour + 0.75 hours x $28.84 per hour). The recordkeeping costs for the remaining
responsibilities, K02-K38, are calculated following the same approach.
Table 6D below provides a summary of the recordkeeping costs by the main entity
responsible. Total estimated annual cost is $27.6 million. Again, even though the proposed
recordkeeping responsibilities would be required from entities other than the sponsor, all costs
are assumed to be ultimately borne by the sponsor funding the nonclinical laboratory study.
Table 6D.--Estimated Annual Recordkeeping Cost
Cost Item Codes

Estimated Cost
($million)

Sponsor

K01-K06

$13.75

Management with executive responsibility

K07-K15

$1.93

Quality Assurance Unit (QAU)
Study Director

K16-K21

$6.36

K22-K32

$5.41

Independent Contributing Scientist

K33-K35

$0.00

Principal Investigator

K36-K38

$0.14

Main Entity Responsible

Total

$27.60

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
We estimate no cost to the Federal government as the information collection is supported by
existing resource allocations.

12

15. Explanation for Program Changes or Adjustments
The information collection is being revised through agency rulemaking. We believe the onetime reporting and recordkeeping burdens introduced by the proposed regulations (cumulatively
estimated to be 9,693 responses and 128,590 hours) will be realized upon their implementation,
if finalized. Also, if the proposal is finalized, existing burden for the information collection as
currently approved (now 36,150 responses and 1,304,157 hours) will be absorbed into the
recurring burden we have estimated for the proposed regulations.
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
Display of OMB Expiration Date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

13