2018-15186. Agency Information Collection Request. 60-Day Public Comment Request

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of proposed extensions of collections for public comment.

DATES:

Comments on the ICR must be received on or before September 17, 2018.

ADDRESSES:

Submit your comments to [e-mail] or by calling [phone].

FOR FURTHER INFORMATION CONTACT:

When submitting comments or requesting information, please include the document identifier 0990-New-60D and project title for reference, to [e-mail], or call the Reports Clearance Officer.

SUPPLEMENTARY INFORMATION:

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Title of the Collection: Crime Control Act—Requirement for Background Checks.

Type of Collection: Extension.

OMB No.: 0990-0430—Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy, and Accountability, Division of Acquisition.

Abstract: Crime Control Act—Requirement for Background Checks: Performance of HHS mission requires the support of contractors. In some circumstances, depending on the requirements of the specific contract, the contractor is tasked to provide personnel who will be dealing with children under the age of 18. After contract award contractor personnel must undergo a background check as required by HHS Acquisition Regulation (HHSAR) 337.103(d)(3) and the clause at HHSAR 352.237-72 Crime Control Act—Requirement for Background Checks before working on the contract as required by federal law (Crime Control Act of 1990). The contractor is therefore required to provide information on the individual so that a proper background check can be performed.

The Agency is requesting a 3 year extension to collect this information from public or private businesses.

Annualized Burden Hour Table

Number of respondents	Total annual responses	Average burden per response (in hours)	Total burden hours
160	160	1	160

Title of the Collection: Acquisitions Involving Human Subjects.

Type of Collection: Extension.

OMB No.: 0990-0431—Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy, and Accountability, Division of Acquisition.

Abstract: Acquisitions Involving Human Subjects: Performance of HHS mission requires the support of contractors involving human subjects. Before awarding a contract to any contractor that will need to use human subjects, the Contracting Officer is required to verify that, the contractor holds a valid Federal Wide Assurance (FWA) approved by the Office for Human Research Protections (OHRP). The provisions are implemented via contract clauses found at HHSAR 352.270-4a (Protection of Human Subjects), the clause at HHSAR 352.270-4b (Protection of Human Subjects), the provision at HHSAR 352.270-10 (Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required), and the clause at HHSAR 352.270-11 (Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required).

The Agency is requesting a 3-year extension to collect this information from public or private businesses.

Annualized Burden Hour Table

Number of respondents	Total annual responses	Average burden per response (in hours)	Total burden hours
90	318	5	1590

Title of the Collection: Acquisitions Involving the Use of Laboratory Animals.

Type of Collection: Extension.

OMB No.: 0990-0432—Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy, and Accountability, Division of Acquisition.

Abstract: Acquisitions Involving the Use of Laboratory Animals: Performance of HHS mission requires the use of live vertebrate animals. Before awarding a contract to any contractor, which will need to use live vertebrate animals, the Contracting Officer is required to verify that the contractor holds a valid Animal Welfare Assurance from the Office of Laboratory Animal Welfare (OLAW) within NIH. Contractors are required to file the appropriate forms to obtain this approval. 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.

Annualized Burden Hour Table

Number of respondents	Total annual responses	Average burden per response (in hours)	Total burden hours
36	41	3	123

Title of the Collection: Indian Child Protection and Family Violence Act.

Type of Collection: Extension.

OMB No. 0990-0433—Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy, and Accountability, Division of Acquisition

Abstract: Indian Child Protection and Family Violence Act: Performance of IHS mission requires the support of contractors. In some circumstances, depending on the requirements of the specific contract, the contractor is tasked to provide personnel who will be dealing with Indian children under the age of 18. After contract award contractor personnel must undergo a background check as required by HHSAR 337.103(d)(4) and the clause at HHSAR 352.237-73 Indian Child Protection and Family Violence Act before working on the contract as required by federal law (Indian Child Protection and Family Violence Act (ICPFVA)). The contractor is therefore required to provide information on the individual so that a proper background check can be performed, as stated in the HHS Acquisition Regulation.

The Agency is requesting a 3-year extension to collect this information from public or private businesses.

Annualized Burden Hour Table

Number of respondents	Total annual responses	Average burden per response (in hours)	Total burden hours
40	160	1	160

Title of the Collection: Meetings, Conferences, and Seminars.

Type of Collection: Extension.

OMB No.: 0990-0434—Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy, and Accountability, Division of Acquisition.

Abstract: Meetings, Conferences, and Seminars: Performance of HHS mission requires the support of contractors. In some circumstances, depending on the requirements of the specific contract, the contractor is tasked to conduct meetings, conferences, and seminars. HHSAR 311.7101(a) (Responsibilities) and the clause at HHSAR 352.211-1 (Accessibility of meetings, conferences and seminars to persons with disabilities) require contractors to provide a plan describing the contractor's ability to meet the accessibility standards in 28 CFR part 36. HHSAR 311.7202(b) (Responsibilities) and the clause at HHSAR 352.211-2 (Conference sponsorship request and conference materials disclaimer) require contractors to provide funding disclosure and a content disclaimer statement on conference materials. As a result of these clauses, HHS contractors providing conference, meeting, or seminars services are required to provide specific information to HHS as stated in the HHS Acquisition Regulation.

The Agency is requesting a 3-year extension to collect this information from public or private businesses.

Annualized Burden Hour Table

Number of respondents	Total annual responses	Average burden per response (in hours)	Total burden hours
1604	1604	1	1604

Title of the Collection: Contractor Collection of Information.

Type of Collection: Extension.

OMB No.: 0990-0436—Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy, and Accountability, Division of Acquisition.

Abstract: Contractor Collection of Information: Performance of HHS mission requires the support of contractors. In some circumstances, depending on the requirements of the specific contract, the contractor is tasked to gather data that involves requesting this data from sources outside of HHS (i.e., the public). In those circumstances HHSAR 352.211-3 Paperwork Reduction Act is included in the contract and prevents the contractor from initiating the solicitation of information from third parties unless and until a proper clearance from OMB has been obtained, specific to that data collection. This clearance covers the data collection necessary to determine what information should be collected in order to prepare the contract-specific OMB clearance request as required by the Paperwork Reduction Act or 1995 44 U.S.C. 3501, and as stated in the HHS Acquisition Regulation.

The Agency is requesting a 3-year extension to collect this information from public or private businesses.

Annualized Burden Hour Table

Number of respondents	Total annual responses	Average burden per response (in hours)	Total burden hours
1	1	1	1

Terry Clark,

Asst. Paperwork Reduction Act Reports Clearance Officer.