2016-21360. Agency Information Collection Activities; Proposed Collection; Public Comment Request

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

DATES:

Comments on the ICR must be received on or before [November 7, 2016].

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Information Collection Clearance staff, [e-mail] or [phone].

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the document identifier HHS-OS-0990-new-60D for reference.

Information Collection Request Title: National Tissue Recovery through Utilization Survey.

Abstract: Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, requesting the Office of Management and Budget (OMB) approval on a new (ICR). This survey is being conducted to generate national estimates of recovery through utilization activity; of donated human tissue for calendar years 2012 and 2015, and to compare metrics across three data collection periods that includes results from a 2007 survey, the most recent year these data were collected. The survey and data collection and analysis methods will be similar to the 2007 survey. The general categories of information to be collected are listed under the Survey Section of the Annualized Burden Hour table below. Policy advice provided by the HHS Advisory Committee on Blood and Tissue Safety and Availability to the HHS Secretary and Assistant Secretary for Health is used to direct departmental efforts to address transfusion and transplantation issues; such as emergency preparedness and infectious disease transmission related to donated human tissue.

Likely Respondents: Respondents for this survey would be U.S. tissue banks that screen and recover tissue from living and deceased donors, and process, store, and/or distribute tissues grafts for transplantation from these donors.

Total Estimated Annualized Burden Hours

Survey section	Type of respondent	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
Tissue bank activities, tissue types handled, and inspections	All tissue banks	110	5	5/60	46
Referrals, authorization, and informed consent; tissue recovery and acquisition	Tissue banks that handle referrals, Recover/acquire tissue	80	36	30/60	1440
Tissue processing	Tissue banks that process tissue	35	17	30/60	298
Tissue storage	Tissue banks that store tissue	65	4	10/60	5
Tissue distribution	Tissue banks that distribute tissue	58	16	15/60	232
Communicable disease testing and adverse outcome reports	Tissue banks that have donor infectious disease testing performed and may handle adverse outcome reports	35	4	30/60	70
Total					2091

OS specifically requests comments on (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.

Terry S. Clark,

Asst Information Collection Clearance Officer.