Notice2022-22204
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
October 13, 2022
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 87 Issue 197 (Thursday, October 13, 2022)</title>
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[Federal Register Volume 87, Number 197 (Thursday, October 13, 2022)]
[Notices]
[Pages 62107-62109]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22204]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0945-0003-60D]
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
[[Page 62108]]
and Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before December 12,
2022.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#6a39020f18180f1e1e0f442c1f04042a020219440d051c"><span class="__cf_email__" data-cfemail="86d5eee3f4f4e3f2f2e3a8c0f3e8e8c6eeeef5a8e1e9f0">[email protected]</span></a> or by calling
(202) 264-0041.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier OS-0945-0003-60D
and project title for reference, to Sherrette A. Funn, email:
<a href="/cdn-cgi/l/email-protection#02516a677070677676672c44776c6c426a6a712c656d74"><span class="__cf_email__" data-cfemail="396a515c4b4b5c4d4d5c177f4c57577951514a175e564f">[email protected]</span></a>, or call (202) 264-0041 the Reports Clearance
Officer.
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: HIPAA Privacy, Security, and Breach
Notification Rules, and Supporting Regulations Contained in 45 CFR
parts 160 and 164.
Type of Collection: Extension.
OMB No. 0945-0003: Office for Civil Rights (OCR)--Health
Information Privacy Division.
Abstract: Office for Civil Rights (OCR) requests approval to extend
this existing, approved collection without changing any collection
requirements. In 2021, OCR published a Notice of Proposed Rulemaking
(NPRM) proposing modifications to the HIPAA Rules that would affect the
hourly burdens associated with the HIPAA Rules. 86 FR 6446. OCR is
reviewing public comment received on the NPRM about existing burdens
associated with compliance with the HIPAA Rules, available at <a href="https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202011-0945-001">https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202011-0945-001</a>, and on
changes in burden that could result from the modifications proposed in
the NPRM. OCR will update this ICR to reflect the input we receive on
this notice and through the rulemaking process.
Likely Respondents: HIPAA covered entities, business associates,
individuals, and professional and trade associations of covered
entities and business associates.
Annualized Burden Hour Table
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Number of Average burden
Section Type of respondent Number of responses per hours per Total burden
respondents respondent response [1] hours
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160.204................................ Process for Requesting Exception 1 1 16 16
Determinations (states or persons).
164.308................................ Risk Analysis--Documentation [2]... 1,700,000 1 10 17,000,000
164.308................................ Information System Activity Review-- 1,700,000 12 0.75 15,300,000
Documentation.
164.308................................ Security Reminders--Periodic 1,700,000 12 1 20,400,000
Updates.
164.308................................ Security Incidents (other than 1,700,000 52 5 442,000,000
breaches)--Documentation.
164.308................................ Contingency Plan--Testing and 1,700,000 1 8 13,600,000
Revision.
164.308................................ Contingency Plan--Criticality 1,700,000 1 4 6,800,000
Analysis.
164.310................................ Maintenance Records................ 1,700,000 12 6 122,400,000
164.314................................ Security Incidents--Business 1,000,000 12 20 240,000,000
Associate reporting of incidents
(other than breach) to Covered
Entities.
164.316................................ Documentation--Review and Update 1,700,000 1 6 10,200,000
[3].
164.404................................ Individual Notice--Written and 58,482 1 0.5 29,241
Email Notice (drafting) [4].
164.404................................ Individual Notice--Written and 58,482 1 0.5 29,241
Email Notice (preparing and
documenting notification).
164.404................................ Individual Notice--Written and 58,482 1,941 0.008 908,108
Email Notice (processing and
sending) [5].
164.404................................ Individual Notice--Substitute 2,746 1 1 2,746
Notice (posting or publishing) [6].
164.404................................ Individual Notice--Substitute 2,746 1 3.42 9,391
Notice (staffing toll-free number)
[7].
164.404................................ Individual Notice--Substitute 113,264 1 0.125 14,158
Notice (individuals' voluntary
burden to call toll-free number
for information) [8], [9].
164.406................................ Media Notice [10].................. 267 1 1.25 334
164.408................................ Notice to Secretary (notice for 267 1 1.25 334
breaches affecting 500 or more
individuals).
164.408................................ Notice to Secretary (notice for 58,215 1 1 58,215
breaches affecting fewer than 500
individuals) [11].
164.410................................ Business Associate notice to 20 1 50 1,000
Covered Entity--500 or more
individuals affected.
164.410................................ Business Associate notice to 1,165 1 8 9,320
Covered Entity--Less than 500
individuals affected.
164.414................................ 500 or More Affected Individuals 267 1 50 13,350
(investigating and documenting
breach).
164.414................................ Less than 500 Affected Individuals 2,479 1 8 19,832
(investigating and documenting
breach)--affecting 10-499.
164.414................................ Less than 500 Affected Individuals 55,736 1 4 222,944
(investigating and documenting
breach)--affecting <10.
[[Page 62109]]
164.504................................ Uses and Disclosures-- 700,000 1 0.083333333 58,333
Organizational Requirements.
164.508................................ Uses and Disclosures for Which 700,000 1 1 700,000
Individual authorization is
required.
164.512................................ Uses and Disclosures for Research 113,524 1 0.083333333 9,460
Purposes [12].
164.520................................ Notice of Privacy Practices for 100,000,000 1 0.004166667 416,667
Protected Health Information
(health plans--periodic
distribution of NPPs by paper
mail) [13], [18].
164.520................................ Notice of Privacy Practices for 100,000,000 1 0.002783333 278,333
Protected Health Information
(health plans--periodic
distribution of NPPs by electronic
mail) [19].
164.520................................ Notice of Privacy Practices for 613,000,000 1 0.05 30,650,000
Protected Health Information
(health care providers--
dissemination and acknowledgement)
[14].
164.522................................ Rights to Request Privacy 20,000 1 0.05 1,000
Protection for Protected Health
Information [15].
164.524................................ Access of Individuals to Protected 200,000 1 0.05 10,000
Health Information (disclosures)
[16].
164.526................................ Amendment of Protected Health 150,000 1 0.083333333 12,500
Information (requests).
164.526................................ Amendment of Protected Health 50,000 1 0.083333333 4,167
Information (denials).
164.528................................ Accounting for Disclosures of 5,000 1 0.05 250
Protected Health Information [17].
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Total.............................. ................. 2,070 ................. 921,158,940
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2022-22204 Filed 10-12-22; 8:45 am]
BILLING CODE 4150-28-P
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