Notice2025-17557
Agency Information Collection Request; 60-Day Public Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 11, 2025
Issuing agencies
Health and Human Services Department
Abstract
In compliance with the requirement 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 collection for public comment.
Full Text
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<title>Federal Register, Volume 90 Issue 174 (Thursday, September 11, 2025)</title>
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[Federal Register Volume 90, Number 174 (Thursday, September 11, 2025)]
[Notices]
[Pages 44077-44078]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17557]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. OS-0945-New-60D]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: In compliance with the requirement 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
collection for public comment.
DATES: Comments on the Information Collection Request (ICR) must be
received on or before November 10, 2025.
ADDRESSES: Submit your comments to Conner O'Brien at
<a href="/cdn-cgi/l/email-protection#eda2aebfbd9f849b8c8e94ad85859ec38a829b"><span class="__cf_email__" data-cfemail="5a1519080a28332c3b39231a323229743d352c">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, such as a free copy of the form to be used for the
information collection, please include the document identifier OS-0945-
New-60D and project title for reference, to Conner O'Brien, email:
<a href="/cdn-cgi/l/email-protection#de919d8c8eacb7a8bfbda79eb6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="a9e6eafbf9dbc0dfc8cad0e9c1c1da87cec6df">[email protected]</span></a>, or call (202) 240-3110.
SUPPLEMENTARY INFORMATION: 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.
Title of the Collection: Confidentiality of Substance Use Disorder
Patient Records Complaint.
Type of Collection: New Collection.
OMB No. 0945-New: Office for Civil Rights (OCR)--Health Information
Privacy, Data, and Cybersecurity Division.
Abstract: OCR is requesting Office of Management and Budget (OMB)
approval for a new information collection. Under OCR's delegated civil
enforcement authority, a person may file a complaint with OCR for
alleged noncompliance with 42 CFR part 2 (``Part 2''). OCR will collect
information from individuals using the form, Confidentiality of
Substance Use Disorder Patient Records Complaint, to allow OCR to
collect the minimum information needed from individuals who file
complaints with OCR to form the basis for the initial processing of
such complaints to satisfy the right for an individual to file a
complaint under 42 CFR 2.4(b).
I. Authority
OCR has delegated civil enforcement authority under 42 U.S.C.
290dd-2(f), as amended by section 3221 of the Coronavirus Relief, Aid,
and Economic Security Act, that applies section 1176 of the Social
Security Act (``the Act''), 45 U.S.C. 1320d-5, to a violation of Part 2
in the same manner as it applies to a violation of part C of title XI
of the Act, Administrative Simplification. The Administrative
Simplification provisions were added to the Act by the Health Insurance
Portability and Accountability Act of 1996 (HIPAA). OCR currently
applies its HIPAA enforcement authority under section 1176 of the Act
in accordance with 45 CFR part 160. To implement 42 U.S.C. 290dd-2, the
Department published a final rule modifying Part 2, 89 FR 12472
(February 16, 2024) (``2024 Part 2 Final Rule''), that included, among
other provisions, a new right to file complaints of noncompliance and
applied 45 CFR part 160, subparts C, D, and E, as the enforcement
regulation for Part 2.
II. Method of Collection
Individuals will be able to submit a Part 2 complaint using the HHS
OCR online complaint portal or by filling out a copy of the form
obtained from OCR's website and submitting it to OCR electronically or
by postal mail.
[[Page 44078]]
III. Estimated Burden
The estimated burden on individuals for gathering information and
completing the Part 2 complaint form is 45 minutes per complaint based
on the hourly burden for HIPAA complaints. Assuming that 1 in every
1,000 patients treated for SUD would file a Part 2 complaint, the
Department estimates a total of 1,398 burden hours for 1,864 complaints
annually (1,864,367 patients/1,000 x .75 hours = 1,398).
Likely Respondents: Patients of substance use disorder treatment
programs who believe that a Part 2 program, covered entity, business
associate, qualified service organization, or other lawful holder of
Part 2 records is noncompliant with 42 CFR part 2.
Annualized Burden Hour Table
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Number of Average burden
Forms (if necessary) Respondents (if Number of responses per per response Total burden
necessary) respondents respondents (minutes) hours
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Complaint Form................ Patients of 1,864 1 45 1,398
Substance Use
Disorder
Treatment
Programs.
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Total..................... ................ 1,864 .............. .............. 1,398
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Catherine Howard,
Paperwork Reduction Act Reports Clearance Officer, Department of Health
and Human Services, Office of the Secretary.
[FR Doc. 2025-17557 Filed 9-10-25; 8:45 am]
BILLING CODE 4153-01-P
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