Notice2026-00499
Agency Information Collection Request; 30-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
January 13, 2026
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, submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. OMB will accept further comments from the public during the review and approval period.
Full Text
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<title>Federal Register, Volume 91 Issue 8 (Tuesday, January 13, 2026)</title>
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[Federal Register Volume 91, Number 8 (Tuesday, January 13, 2026)]
[Notices]
[Pages 1325-1326]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-00499]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0945-NEW-30D]
Agency Information Collection Request; 30-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, submitted an Information Collection Request (ICR) to
the Office of Management and Budget (OMB) for review and approval. OMB
will accept further comments from the public during the review and
approval period.
DATES: Comments on the Information Collection Request (ICR) must be
received on or before February 12, 2026.
[[Page 1326]]
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice via <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this
information collection by selecting
``Currently under Review'' and ``Select Agency: Department of
Health and Human Services''.
FOR FURTHER INFORMATION CONTACT: When 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-30D and project title for
reference, to Conner O'Brien by email at <a href="/cdn-cgi/l/email-protection#0b4448595b79627d6a68724b636378256c647d"><span class="__cf_email__" data-cfemail="19565a4b496b706f787a605971716a377e766f">[email protected]</span></a>, or by
phone at (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 Form.
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. OCR published a 60-day
notice in the Federal Register on September 11, 2025,\1\ and, following
a government shutdown, OCR reopened the comment period for an
additional 47 days on November 19, 2025.\2\ No public comments were
received. 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 of
an individual to file a complaint under 42 CFR 2.4(b).
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\1\ 90 FR 44077 (September 11, 2025).
\2\ 90 FR 52070 (November 19, 2025).
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I. Authority
OCR has delegated civil enforcement authority \3\ under 42 U.S.C.
290dd-2(f), as amended by section 3221 of the Coronavirus Aid, Relief,
and Economic Security Act, which 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
exercises its enforcement authority under section 1176 of the Act to
enforce the HIPAA Privacy, Security, and Breach Notification Rules
(collectively, ``HIPAA Rules'') in accordance with 45 CFR part 160
(``Enforcement Rule''). To implement 42 U.S.C. 290dd-2, as amended, the
Department published a final rule modifying Part 2, 89 FR 12472
(February 16, 2024) (``2024 Part 2 Final Rule''), which 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.
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\3\ 90 FR 41833 (August 27, 2025).
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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.
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.
Estimated Annualized Burden Table:
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Number of Average burden
42 CFR Type of respondent Number of responses per Total hours per Total burden
respondents respondent responses response hours
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2.4.................................. Individuals filing a Part 2 1,864 1 1,864 0.75 1,398
complaint.
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Catherine Howard,
Paperwork Reduction Act Reports Clearance Officer, Department of Health
and Human Services, Office of the Secretary.
[FR Doc. 2026-00499 Filed 1-12-26; 8:45 am]
BILLING CODE 4153-01-P
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