E9-10317. Agency Information Collection Request; 60-Day Public Comment Request

AGENCY:

Office of the Secretary, HHS.

In compliance with the requirement of section 3506(c)(2)(A) 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 a proposed information collection request for public comment. 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. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to [e-mail], or call the Reports Clearance Office on [phone]. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above e-mail address within 60-days.

Proposed Project: Standards for Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164 (Extension)- OMB No. 0990-0294 Office of Civil Rights.

Abstract: The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996. The final regulation requires covered entities (as defined in the regulation) to maintain strong protections for the privacy of individually identifiable health information; to use or disclose this information only as required or permitted by the Rule or with the express written authorization of the individual; to provide a notice of the entity's privacy practices; and to document compliance with the Rule. Respondents are health care providers with health plans, and health care clearinghouses. The affected public includes individuals, public and private businesses, state and local governments.

Estimated Annualized Burden Table

Section	Type of respondent	Number of respondents	Number of responses per respondent	Average burden hours per response	Total burden hours
160.204	Process for Requesting Exception Determinations (states or persons)	40	1	16	640
164.504	Uses and Disclosures—Organizational Requirements	764,799	1	5/60	63,733
164.508	Uses and Disclosures for Which Individual authorization is required	764,799	1	1	764,799
164.512	Uses and Disclosures for which Consent, Individual Authorization, or Opportunity to Agree or Object is Not Required (for other specified purposes by an IRB or privacy board)	113,524	1	5/60	9,460
164.520	Notice of Privacy Practices for Protected Health Information (health plans)	10,570	1	3/60	529
164.520	Notice of Privacy Practices for Protected Health Information (health care providers—dissemination)	613,000,000	1	3/60	30,650,000
164.520	Notice of Privacy Practices for Protected Health Information (health care providers—acknowledgement)	613,000,000	1	3/60	30,650,000
164.522	Rights to Request Privacy Protection for Protected Health Information	150,000	1	3/60	7,500
164.524	Access of Individuals to Protected Health Information (disclosures)	150,000	1	3/60	7,500
164.526	Amendment of Protected Health Information (requests)	150,000	1	3/60	7,500
164.526	Amendment of Protected Health Information (denials)	50,000	1	3/60	2,500
164.528	Accounting for Disclosures of Protected Health Information	1,080,000	1	5/60	90,000
Total					62,254,161

Terry Nicolosi,

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