E7-25659. Proposed Information Collection (Informed Consent for Patient Care); Comment Request

AGENCY:

Veterans Health Administration, Department of Veterans Affairs.

ACTION:

Notice.

SUMMARY:

The Veterans Health Administration (VHA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the disclosure requirements imposed on non-VA physicians to ensure that patients have sufficient information to provide educated and informed consent for medical procedures.

DATES:

Written comments and recommendations on the proposed collection of information should be received on or before March 7, 2008.

ADDRESSES:

Submit written comments on the collection of information through www.Regulations.gov; or to Mary Stout, Veterans Health Administration (193E1), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420 or e-mail: [e-mail]. Please refer to “OMB Control No. 2900-0583” in any correspondence. During the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Mary Stout [phone] or FAX [phone].

SUPPLEMENTARY INFORMATION:

Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.

With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.

Title: Regulation for Informed Consent for Patient Care (Title 38 CFR 17.32).

OMB Control Number: 2900-0583.

Type of Review: Extension of a currently approved collection.

Abstract: VA informed consent regulation describes patient rights and responsibilities and the process for obtaining informed consent. It contains procedures that providers (including non-VA physicians who contract to perform services for VA on a fee-basis) must follow when seeking informed consent from a VA beneficiary (e.g., discussion of the benefits, risk and alternatives for the recommended treatment or procedure and documentation of the patient's decision). The information provided is designed to ensure that the patients (or, when appropriate, the patient's representative or surrogate) have sufficient information to provide informed consent.

Affected Public: Individuals or households.

Estimated Total Annual Burden: 8,000 hours.

Estimated Average Burden per Respondent: 15 minutes.

Frequency of Response: On occasion.

Estimated Number of Respondents: 32,000.

Dated: December 27, 2007.

By direction of the Secretary.

Denise McLamb,

Program Analyst, Records Management Service.