06-6813. Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Forms To Implement the Privacy Rule (45 CFR Parts 160 & 164)

AGENCY:

Indian Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval.

The IHS received no comments in response to the 60-day Federal Register (71 FR 31195) published on June 1, 2006. The purpose of this notice is to allow an additional 30 days for public comment to be submitted directly to OMB.

Proposed Collection

Title: 0917-0030, “Indian Health Service Forms to Implement the Privacy Rule (45 CFR parts 160 & 164)”.

Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0030. “Indian Health Service Forms to Implement the Privacy Rule (45 CFR parts 160 & 164)”.

Form Number: IHS-810, IHS-912-1, IHS-912-2, IHS-913, and IHS-917.

Need and Use of Information Collection: This collection of information is made necessary by the Department of Health and Human Services Rule entitled “Standards for Privacy of Individual Identifiable Health Information” (“Privacy Rule”) (45 CFR parts 160 and 164). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Information Portability and Accountability Act of 1996 and creates national standards to protect individual's person health information and gives patients increased access to their medical records. 45 CFR 164.508, 522, 526 and 528 of the Rule require the collection of information to implement these protection standards and access requirements. The IHS will use the following data collection instruments to implement the information collection requirements contained in the Rule.

45 CFR 164.508: This provision requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information for other than for treatment, payment and healthcare operations. Under the provision individuals may initiate a written authorization permitting covered entities to release their protected health information to entities of their choosing. The IHS-810 will be used to document an individual's authorization to use or disclose their protected health information.

45 CFR 164.522: Section 164.522(a)(1) requires a covered entity to permit individuals to request that the covered entity restrict the use and disclosure of their protected health information. The covered entity may or may not agree to the restriction. The form IHS-912-1 “Request for Restriction(s)” will be used to document an individual's request for restriction of their protected health information and whether IHS agreed or disagreed with the restriction. Section 164.522(a)(2)(1) permits a covered entity to terminate its agreement to a restriction if the individual agrees to or requests the termination in writing. The form IHS-912-2 “Request for Revocation of Restriction(s)” will be used to document the agency or individual request to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information.

45 CFR 164.526: This provision requires covered entities to permit an individual to request that the covered entity amend protected health information. If the covered entity accepts the requested amendment, in whole or in part, the covered entity must inform the individual that the amendment is accepted and obtain the individual's identification of an agreement to have the covered entity notify the relevant persons with which the amendment needs to be shared. If the covered entity denies the requested amendment, in whole or in part, the covered entity must provide the individual with a written denial. The form IHS-917 “Request for Correction/Amendment of Protected Health Information” will be used to document an individual's request to amend their protected health information and the agency's decision to accept or deny the request.

45 CFR 164.528: This provision requires covered entities to permit an individual to request that the covered entity provide an accounting of disclosures of protected health information made by the covered entity. The form IHS-913 “Request for an Accounting of Disclosures” will be used to document an individual's request for an accounting of disclosures of their protected health information and the agency's handling of the request.

Completed forms used in this collection of information are filed in the medical record.

Affected Public: Individuals and households.

Type of Respondents: Individuals.

Burden Hours: The table below provides the estimated burden hours for this information collection.

45 CFR section/IHS form	No. of respondents	Responses per respondent	Burden per responses (mins)*	Total annual burden
164.506, IHS-810	500,000	1	20	166,667
164.522(a)(1), IHS-912-1	15,000	1	10	2,500
164.522(a)(2), IHS-912-2	5,000	1	10	833
164.526, IHS-917	7,500	1	15	1,875
164,528, IHS-913	15,000	1	10	2,500
Total Annual Burden		5		174,375
* For ease of understanding, burden hours are provided in actual minutes.

The total estimated burden for this collection of information is 174,375 hours. There are no capital costs, operating costs and/or maintenance costs to respondents

Request For Comments: Your written comments and/or suggestions are invited on one or more of the following points: (a) Whether the information collection activity is necessary to carry out an agency function; (b) whether the agency processes the information collected in a useful and timely fashion; (c) the accuracy of public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information); (c) whether the methodology and assumptions used to determine the estimate are logical; (e) ways to enhance the quality, utility, and clarity of the information being collected; and (f) ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Direct Comments to OMB: Send your written comments and suggestions regarding the proposed information collection contained in this notice, especially regarding the estimated public burden and associated response time, directly to: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC, 20503, Attention: Allison Eydt, Desk Officer for IHS.

FOR FURTHER INFORMATION CONTACT:

Send requests for more information on the proposed collection or to obtain a copy of the data collection instrument(s) and instructions to: Mrs. Christina Rouleau, IHS Reports Clearance Officer, 801 Thompson Avenue, TMP, Suite 450, Rockville, MD 20852-1601, call non-toll free [phone], send via facsimile to [phone], or send your e-mail requests, comments, and return address to: [e-mail].

Comment Due Date: Your comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

Dated: August 3, 2006.

Robert G. McSwain,

Deputy Director, Indian Health Service.