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Agency Information Collection Request. 60-Day Public Comment Request

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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 for public comment the following summary of a request to extend a previously approved information collection. This request does not propose any changes to this information collection related to future modifications of the underlying regulations. 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, email your request, including your address, phone number, OMB number, and OS document identifier, to, or call the Reports Clearance Office on (202) 690-6162. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above email address within 60 days.

Proposed Project: Standards for the Privacy of Individually Identifiable Health Information and Supporting Regulations at 45 CFR Parts 160 and 164 (Extension)—OMB No. 0990-0294—Office for 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 regulations require covered entities (as defined in the regulations) 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, health plans, and health care clearinghouses. The affected public includes individuals, public and private businesses, state and local governments.

Estimated Annualized Burden Table

SectionType of respondentNumber of respondentsNumber of responses per respondentAverage burden (in hours) per responseTotal burden hours
160.204Process for Requesting Exception Determinations (states or persons)40116640
164.504Uses and Disclosures—Organizational Requirements764,79915/6063,733
164.508Uses and Disclosures for Which Individual Authorization Is Required764,79911764,799
164.512Uses and Disclosures for Which Consent, Individual Authorization, or Opportunity to Agree or Object Is Not Required (or other specified purposes by an IRB or privacy board)113,52415/609,460
164.520Notice of Privacy Practices for Protected Health Information (health plans)10,57013/60529
164.520Notice of Privacy Practices for Protected Health Information (health care providers—dissemination)613,000,00013/6030,650,000
164.520Notice of Privacy Practices for Protected Health Information (health care providers—acknowledgment)613,000,00013/6030,650,000
164.522Rights to Request Privacy Protection for Protected Health Information150,00013/607,500
164.524Access of individuals to Protected Health Information (disclosures)150,00013/607,500
164.526Amendment of Protected Health Information (requests)150,00013/607,500
164.526Amendment of Protected Health Information (denials)50,00013/602,500
164.528Accounting for Disclosures of Protected Health Information1,080,00015/6090,000

Keith A. Tucker,

Office of the Secretary, Paperwork Reduction Act Clearance Officer.

[FR Doc. 2012-18335 Filed 7-26-12; 8:45 am]