Supporting Justification
Statement for OMB Control Number 0990-0432
HHSAR
370.401
Circumstances Making the Collection of Information Necessary
The Department of Health and Human Services (HHS), Office of the Assistant Secretary for Financial Resources, Office of Acquisitions is requesting the Office of Management and Budget (OMB) grant an extension on a previously approved information collection request, OMB control number 0990-0432, Acquisitions Involving the Use of Laboratory Animals.
Performance of HHS mission requires the use of live vertebrate animals in accordance with Health Research Extension Act of 1985, Public Law 99-158, “Animals in Research”. Before awarding a contract to any contractor that will need to use live vertebrate animals, the Contracting Officer is required to verify that the contractor holds a valid Animal Welfare Assurance (AWA) from the Office of Laboratory Animal Welfare (OLAW) within the National Institutes of Health, as prescribed in the Health and Human Services Acquisition Regulation (HHSAR) Subpart 370.4—Acquisitions Involving the Use of Laboratory Animals, the applicable clauses are found at HHSAR 352.270-5a (Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals), and the clause at HHSAR 352.270-5b (Care of Live Vertebrate Animals).
The Agency is requesting a 3-year extension to collect this information from public or private businesses.
Purpose and Use of Information Collection
The information is used to determine that a contractor has a valid AWA. Before a contract is awarded contractors must show that they obtained an AWA or are in the process of obtaining an AWA. The NIH Office of Laboratory Animal Welfare (OLAW) issues AWA’s for relevant contractors.
Use of Improved Information Technology and Burden Reduction
All data submitted by contractors (100 percent) is requested to be submitted electronically. We use improved information technology to the maximum extent practicable. Where contractors are capable of electronic interchange, the contractors may submit this information collection requirement electronically. Nothing in the HHSAR precludes the use of electronic interchange where the requirement is for written documents. The information necessary to verify that the contractor has secured a valid AWA approved by NIH/OLAW is collected at the time of proposal submittal. When the AWA has not been approved, the contracting officer shall designate a time period in which the AWA must be approved.
Efforts to Identify Duplication and Use of Similar Information
Each contractor is required to obtain this approval before performing contract work associated with the use of live vertebrate animals. The AWA may need to be periodically renewed with OLAW. There is no duplication of such application except as required by the periodic renewals.
Impact on Small Businesses or Other Small Entities
The requirements of the AWA apply regardless of the size of the contractor. The data being requested is being provided by the contractor pursuant to the contract requirements. Any burden would be the same for any size entity and is necessary for performance of the specific contract. The contract price would reflect the contract requirements. Thus, there is no additional burden or excessive burden placed on small businesses.
Consequences of Collecting the Information; Less Frequent Collection
Collection efforts by contractors are in response to specific contract requirements that are drafted to address specific missions of HHS. While a contractor might hold several contracts involving the use of live vertebrate animals, only one AWA is required to approve the facility and protocols. Thus, in most cases, each contractor would have a single application to OLAW for purposes of gathering the data necessary for the approval. The resulting AWA can possibly be used across multiple contracts.
Special Circumstances Relating to the Guidelines of 5 CFR Part 1320.5
There are no special circumstances related to collection of this information.
There are no requirements to report information to the agency more often than quarterly.
Generally, contractors will be required to provide the requisite information with proposal submission. In most cases contractors will have 30 days or more to prepare a proposal submission. With contracting officer approval, the contractor may submit an AWA within a specified time frame after proposal submission.
Contractors will not be required to submit more than an original and two copies of any document. In virtually all cases, an electronic submission is sufficient.
Contract laws and regulations specify record retention requirements for contracts.
It is not expected that any contractor would be required to use a statistical data classification that has not been reviewed and approved by OMB. The information collected does not include statistical data.
The protection of contractor proprietary, trade secret, or other confidential information and the Government’s right to use that data are covered by contract-specific clauses.
The request fully complies with the regulation.
Comments in Response to the Federal Register Notice/Outside Consultation
A 60-day Federal Register Notice was published in the Federal Register on August 16, 2021, vol. 86, No. 155; pp: 45740-45742 (see attachment 0990-0432-resources.docx). No public comments related to data collection were received.
Explanation of any Payment/Gift to Respondents
There will be no payments or gifts offered to the respondents for this collection of information. This collection of information will be part of the requirements of a federal contract.
Assurance of Confidentiality Provided to Respondents
Data will be kept private to the extent allowed by law. This contract clause merely requires the contractor to provide assurance that the contractor has obtained an AWA. This information collection does not include personally identifiable information. Information provided to HHS by a contractor is subject to being requested by third parties under the Freedom of Information Act (FOIA), as amended (5 U.S.C. 552), but business proprietary information is generally exempt from public disclosure under the FOIA. AWA application information is about contractor entities so does not constitute Privacy Act records. The information in this supporting statement has been reviewed by HHS privacy personnel.
Justification for Sensitive Questions
No sensitive questions are asked of contractors under this data collection.
Estimates of Annualized Hour and Cost Burden
12.A. Estimated Annualized Burden Hours
Type of Respondent |
Number of Respondents |
No. Responses per Respondent |
Average Burden per Response (in hours) |
Total Burden Hours |
Business (contractor) |
36 |
1 |
3 |
108 |
Total |
36 |
1 |
3 |
108 |
12.B. Estimated Annualized Burden Costs
Type of Respondent |
Total Burden Hours |
Hourly Wages |
Total Cost to the Respondents |
Business (contractor) |
108 |
$63.78 |
$6,888.24 |
Estimates of Other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs
There are no capital costs associated with this collection.
Annualized Cost to Federal Government
There are no equipment or overhead costs. Government FTEs and contractors, however, are being used to support the data collection. The cost to the federal government would be the cost of the salaries of the HHS staff that collects and disseminates the data and the cost of the contractor staff that supports the analysis and submission of the data.
The total estimated annualized cost to the federal government is $7,761.00. Table A-14 describes how this cost estimate was calculated and the roles.
Table A-14: Estimated Annualized Cost to the Federal Government
Organization |
Role |
Rate |
Hours |
Cost |
OS/ASFR/OA |
Federal SME |
$82.65 |
40 |
$3,306.00 |
Contractor |
Contractor Analyst |
$104.00 |
30 |
$3,102.00 |
Contractor |
Contractor Staff Support |
$89.00 |
15 |
$1,335.00 |
Total |
|
|
85 |
$7,761.00 |
Explanation for Program Changes or Adjustments
This is an extension of the current collection effort. There was no change to the current OMB inventory burden hours of 108 hours.
Plans for Tabulation and Publication and Project Time Schedule
Approval is requested by February 16, 2022 to allow for continued use of the HHSAR clauses.
Reason(s) Display of OMB Expiration Date is Inappropriate
There is no request to not display the OMB Expiration Date.
Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
SECTION B STATISTICAL METHODOLOGY
This does not require any statistical or other analysis.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Tom Reid |
| File Modified | 0000-00-00 |
| File Created | 2021-12-22 |