[Federal Register Volume 74, Number 195 (Friday, October 9, 2009)]
[Notices]
[Page 52235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24471]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier 0990-0346]


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 [email protected], 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 e-mail 
address within 60 days.
    Proposed Project: HITECH Act Breach Notification--OMB No. 0990-
0346-Extension--Office of Civil Rights.
    Abstract: The Health Information Technology for Economic and 
Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of 
Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) 
(Pub. L. 111-5) requires the Office for Civil Rights to collect 
information regarding breaches discovered by covered entities and their 
business associates under the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) Privacy Rule (45 C.F.R. Part 160 and 
Subparts A and E of Part 164). ARRA was enacted on February 17, 2009. 
The Department of Health and Human Services (HHS) issued interim final 
regulations on August 24, 2009 (74 FR 42740), which became effective 
September 23, 2009, to require HIPAA covered entities and their 
business associates to provide notification in the case of breaches of 
unsecured protected health information. Section 164.404 of this interim 
final regulation requires HIPAA covered entities to notify affected 
individuals of a breach of their unsecured protected health information 
and, in some cases, to notify the media of such breaches pursuant to 
Sec.  164.406. Section 164.408 requires covered entities to provide the 
Secretary with immediate notice of all breaches of unsecured protected 
health information involving more than 500 individuals. Additionally, 
the Act requires covered entities to provide the Secretary with an 
annual log of all breaches of unsecured protected health information 
that involve less than 500 individuals. Finally, business associates 
must notify the covered entity of any breaches that occur subject to 
Sec.  164.410.

Estimated Annualized Burden Table

----------------------------------------------------------------------------------------------------------------
                                                                  Average number  Average burden
               Type of respondent                    Number of     of responses      hours per     Total burden
                                                    respondents   per respondent     response          hours
----------------------------------------------------------------------------------------------------------------
Individual Notice--Written and E-mail Notice                 106               1             206          21,836
 (drafting, preparing, sending, and documenting
 notification)..................................
500 or More Affected Individuals (investigating               56               1              44           2,464
 and documenting breach)........................
Less than 500 Affected Individuals                            50               1               8             400
 (investigating and documenting breach).........
Individual Notice--Substitute Notice (posting or              70               1               1              70
 publishing)....................................
Individual Notice--Substitute Notice (toll-free               70               1           3,438         240,660
 number)........................................
Media Notice....................................              56               1               1              56
Notice to Secretary (notice for breaches                     106               1          140/60             247
 affecting 500 or more individuals and annual
 notice and maintenance of annual log)..........
                                                 ---------------------------------------------------------------
    TOTAL.......................................  ..............  ..............  ..............         265,733
----------------------------------------------------------------------------------------------------------------


Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Reports Clearance 
Officer.
[FR Doc. E9-24471 Filed 10-8-09; 8:45 am]
BILLING CODE 4153-01-P