84 FR 139 pgs. 34905-34907 - Agency Information Collection Request. 60-Day Public Comment Request
Type: NOTICEVolume: 84Number: 139Pages: 34905 - 34907
Pages: 34905, 34906, 34907Docket number: [Document Identifier: OS-0945-0003-60D]
FR document: [FR Doc. 2019-15323 Filed 7-18-19; 8:45 am]
Agency: Health and Human Services Department
Official PDF Version: PDF Version
[top]
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.
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 ICR must be received on or before September 17, 2019.
ADDRESSES:
Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795-7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or requesting information, please include the document identifier 0945-0003-60D, and project title for reference, to Sherrette Funn, the Reports Clearance Officer, Sherrette.funn@hhs.gov, or call 202-795-7714.
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 collecting requirements while OCR obtains public comment through a Notice of Proposed Rulemaking (NPRM) proposing modifications to the HIPAA Rules that will affect the hourly burdens associated with the Rules. When the NPRM is published, we expect to receive robust public comment on existing burdens associated with compliance with the HIPAA Rules 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.
[top]
| Forms (if necessary) | Respondents (if necessary) | Number of respondents | Number of responses per respondents | Average burden per response | Total burden hours |
|---|---|---|---|---|---|
| 45 CFR 160.204: Process for Requesting Exception Determinations (states or persons) | A state's chief elected official or designee | 1 | 1 | 16 | 16 |
| 45 CFR 164.308: Risk Analysis-Documentation | Covered entities; business associates | 1,700,000 | 1 | 10 | 17,000,000 |
| 45 CFR 164.308: Information System Activity Review-Documentation | Covered entities; business associates | 1,700,000 | 12 | 0.75 | 15,300,000 |
| 45 CFR 164.308: Security Reminders-Periodic Updates | Covered entities; business associates | 1,700,000 | 12 | 1 | 20,400,000 |
| 45 CFR 164.308: Security Incidents (other than breaches)-Documentation | Covered entities; business associates | 1,700,000 | 52 | 5 | 442,000,000 |
| 45 CFR 164.308: Contingency Plan-Testing and Revision | Covered entities; business associates | 1,700,000 | 1 | 8 | 13,600,000 |
| 45 CFR 164.308: Contingency Plan-Criticality Analysis | Covered entities; business associates | 1,700,000 | 1 | 4 | 6,800,000 |
| 45 CFR 164.310: Maintenance Records | Covered entities; business associates | 1,700,000 | 12 | 6 | 122,400,000 |
| 45 CFR 164.314: Security Incidents-Business Associate reporting of incidents (other than breach) to Covered Entities | Business associates | 1,000,000 | 12 | 20 | 240,000,000 |
| 45 CFR 164.316: Documentation-Review and Update | Covered entities; business associates | 1,700,000 | 1 | 6 | 10,200,000 |
| 45 CFR 164.404: Individual Notice-Written and E-mail Notice (drafting) | Covered entities | 58,481 | 1 | 0.5 | 29,241 |
| 45 CFR 164.404: Individual Notice-Written and E-mail Notice (preparing and documenting notification) | Covered entities | 58,481 | 1 | 0.5 | 29,241 |
| 45 CFR 164.404: Individual Notice-Written and E-mail Notice (processing and sending) | Covered entities | 58,481 | 353 | 0.008 | 165,150 |
| 45 CFR 164.404: Individual Notice-Substitute Notice (posting or publishing) | Covered entities | 2,746 | 1 | 1 | 2,746 |
| 45 CFR 164.404: Individual Notice-Substitute Notice (staffing toll-free number) | Covered entities | 2,746 | 1 | 5.75 | 15,790 |
| 45 CFR 164.404: Individual Notice-Substitute Notice (individuals' voluntary burden to call toll-free number for information) | Covered entities | 11,326,440 | 1 | 0.125 | 1,415,805 |
| 45 CFR 164.406: Media Notice | Covered entities | 267 | 1 | 1.25 | 334 |
| 45 CFR 164.408: Notice to Secretary (notice for breaches affecting 500 or more individuals) | Covered entities | 267 | 1 | 1.25 | 334 |
| 45 CFR 164.408: Notice to Secretary (notice for breaches affecting <500 individuals) | Covered entities | 58,215 | 1 | 1 | 58,215 |
| 45 CFR 164.410: Business associate notice to covered entity-500 or more Affected Individuals | Business associates | 20 | 1 | 50 | 1,000 |
| 45 CFR 164.410: Business associate notice to covered entity-Less than 500 Affected Individuals | Business associates | 1,165 | 1 | 8 | 9,320 |
| 45 CFR 164.414: 500 or More Affected Individuals (investigating and documenting breach) | Covered entities | 267 | 1 | 50 | 13,350 |
| 45 CFR 164.414: Less than 500 Affected Individuals (investigating and documenting breach)-affecting 10-499 | Covered entities | 2,479 | 1 | 8 | 19,832 |
| 45 CFR 164.414: Less than 500 Affected Individuals (investigating and documenting breach)-affecting <10 | Covered entities | 55,736 | 1 | 4 | 222,944 |
| 45 CFR 164.504: Uses and Disclosures-Organizational Requirements | Covered entities | 700,000 | 1 | 0.083333333 | 58,333 |
| 45 CFR 164.508: Uses and Disclosures for Which Individual authorization is required | Covered entities | 700,000 | 1 | 1 | 700,000 |
| 45 CFR 164.512: Uses and Disclosures for Research Purposes | Covered entities | 113,524 | 1 | 0.083333333 | 9,460 |
| 45 CFR 164.520: Notice of Privacy Practices for Protected Health Information (health plans-periodic distribution of NPPs by paper mail) | Covered entities-health plans | 100,000,000 | 1 | 0.004166667 | 416,667 |
| 45 CFR 164.520: Notice of Privacy Practices for Protected Health Information (health plans-periodic distribution of NPPs by electronic mail) | Covered entities-health plans | 100,000,000 | 1 | 0.002783333 | 278,333 |
| 45 CFR 164.520: Notice of Privacy Practices for Protected Health Information (health care providers-dissemination and acknowledgement) | Covered entities-health care providers | 613,000,000 | 1 | 0.5 | 30,650,000 |
| 45 CFR 164.522: Rights to Request Privacy Protection for Protected Health Information | Covered entities-health care providers, health plans | 20,000 | 1 | 0.5 | 1,000 |
| 45 CFR 164.524: Access of Individuals to Protected Health Information (disclosures) | Covered entities-health care providers, health plans, clearinghouses | 200,000 | 1 | 0.5 | 10,000 |
| 45 CFR 164.526: Amendment of Protected Health Information (requests) | Covered entities-health care providers, health plans, clearinghouses | 150,000 | 1 | 0.083333333 | 12,500 |
| 45 CFR 164.526: Amendment of Protected Health Information (denials) | Covered entities-health care providers, health plans, clearinghouses | 50,000 | 1 | 0.083333333 | 4,167 |
| 45 CFR 164.528: Accounting for Disclosures of Protected Health Information | Covered entities-health care providers, health plans, clearinghouses | 5,000 | 1 | 0.05 | 250 |
| Total | 921,824,027 |
[top]
Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer.
[FR Doc. 2019-15323 Filed 7-18-19; 8:45 am]
BILLING CODE 4150-28-P