Agency Information Collection Activities; Proposed Collection; Public Comment Request

---
identifier: "/us/fr/2019-19857"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Agency Information Collection Activities; Proposed Collection; Public Comment Request"
title_number: 0
title_name: "Federal Register"
section_number: "2019-19857"
section_name: "Agency Information Collection Activities; Proposed Collection; Public Comment Request"
positive_law: false
currency: "2019-09-13"
last_updated: "2019-09-13"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2019-19857"
document_type: "notice"
publication_date: "2019-09-13"
agencies:
  - "Health and Human Services Department"
fr_citation: "84 FR 48359"
fr_volume: 84
docket_ids:
  - "Document Identifier: OS-0990-XXXX"
comments_close_date: "2019-11-12"
fr_action: "Notice."
---


#  Agency Information Collection Activities; Proposed Collection; 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 (HHS), is publishing the following summary of a proposed collection for public comment.

**DATES:**

Comments on the ICR must be received on or before November 12, 2019.

**ADDRESSES:**

Submit your comments to *[email protected]* or by calling (202) 795-7714.

**FOR FURTHER INFORMATION CONTACT:**

When submitting comments or requesting information, please include the document identifier 0990-New-60D and project title for reference to *[email protected],* 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.

*Information Collection Request Title:* 0990-XXXX—Subpart C Research Certification Form.

*Abstract:* Assistant Secretary for Health, Office for Human Research Protections is requesting a new information collection, on the Subpart C Research Certification Form. The purpose of the IRB Registration Form is to provide a simplified, standardized procedure for institutions to submit subpart C research certifications to OHRP in order to obtain authorization to include prisoners in human subjects research as required in 45 CFR 46.305(c).

*Likely Respondents:* Institutions or Organizations operating IRBs that have enrolled or are planning to enroll prisoners in human subject research conducted or supported by HHS.

| Form name | Number of | Average | Total burden hours |
| --- | --- | --- | --- |
| Subpart C Certification Form | 80 | 1 | 80 |
| Total |  |  | 80 |

Terry Clark,

Office of the Secretary, Asst Paperwork Reduction Act Reports Clearance Officer.