2010-25657. Agency Information Collection Activities: Submission for OMB Review; Comment Request

Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, e-mail [e-mail] or call the HRSA Reports Clearance Office on [phone].

The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:

Proposed Project: Healthcare Integrity and Protection Data Bank for Final Adverse Information on Health Care Providers, Suppliers and Practitioners (45 CFR 61)—OMB No. 0915-0239—Revision

This is a request for revision and extension of OMB approval of the information collections contained in regulations found in 45 CFR Part 61 governing the Healthcare Integrity and Protection Data Bank (HIPDB) and the forms to be used in reporting information to and requesting information from the HIPDB cleared under OMB No. 0915-0239. An additional form entitled, “Instructions for Registering as an NPDB-HIPDB Self-Querier,” has been included to meet identity proofing and e-authentication requirements stipulated in the E-Authentication Guidance for Federal Agencies (OMB M-04-04) and National Institutes of Standards and Technology's (NIST) Draft Special Publication 800-63-1, Electronic Authentication Guidelines. The burden estimate for self-queriers has been adjusted from the original OMB approval to reflect this new registration process. The HIPDB is authorized by section 1128E of the Social Security Act (hereinafter referred to as section 1128E), as added by section 221(a) of the Health Insurance Portability and Accountability Act of 1996. Section 1128E directs the Secretary of Health and Human Services (the Secretary) to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions (excluding settlements in which no findings of liability have been made) taken against health care providers, suppliers, or practitioners. It also directs the Secretary to maintain a database of final adverse actions taken against health care providers, suppliers, or practitioners. The regulations implementing section 1128E governing the operation of the HIPDB are codified at 45 CFR Part 61. The HIPDB became operational November 22, 1999.

Approval is requested to continue the following reporting data collection and disclosure requirements and the ensuing HIPDB forms along with the instructions. The recordkeeping, reporting, and disclosure requirements are specified in the regulations to implement the HIPDB. Numbers in the table may not add up exactly due to rounding. Please note the burden for Administrative Forms has been accounted for in the NPDB OMB clearance renewal submission.

The annual estimate of burden is as follows:

Distribution of Burden by Regulatory Citation

Regulation citation	Number of respondents	Responses per respondent	Total responses	Hours per response (in minutes)	Total burden hours	Wage rate	Total cost
§ 61.6(a), (b) Errors & Omissions	188	4.4	817	15	204.25	$25	$5,106
§ 61.6 Revisions/Appeal Status	130	26.9	3,492	30	1,746	25	43,650
§ 61.7 Reporting By State Licensure Boards	305	80.8	24,640	45	18,480	25	462,000
§ 61.8 Reporting of State Criminal Convictions	45	56	2,518	45	1,888.5	43	81,205
§ 61.9 Reporting of Civil Judgments	4	2.5	10	45	7.5	43	322
§ 61.10(b) Reporting Exclusions from participation in Federal and State Health Care Programs	9	320.3	2,883	20	961.0	38	36,518
§ 61.11 Reporting of Adjudicated Actions/Decisions	92	17	1,562	45	1,171.5	43	50,375
§ 61.12 Request for Information: State and Federal Agencies	855	279.3	238,814	5	19,901.26	25	497,531.50
§ 61.12 Request for Information Health Plans	1,239	532.4	659,617	5	54,968.1	30	1,649,043
§ 61.12 Request for Information Health Care Providers, Suppliers and Practitioners (self-query)	50,416	1	50,416	55	46,214.7	45	2,079,661.50
§ 61.12(a)(4) Requests by Researchers for Aggregate Data	1	1	1	30	.5	38	19
§ 61.15 Dispute Report	300	1	300	5	25	45	1,125
§ 61.15 Add Report Statement	669	1	669	45	501.8	100	50,180
§ 61.15 Request for Secretarial Review	15	1	15	480	120	200	24,000
Administrative Forms	0	0	0	0	0	0	0
Total	54,268		985,754		146,190.11		4,980,736

Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to [e-mail] or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.”

Dated: October 6, 2010.

Wendy Ponton,

Director, Office of Management.