81 FR 26566 - Privacy Act of 1974; Report of New System of Records
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 85 (May 3, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 85 (May 3, 2016)
| Page Range | 26566-26569 | |
| FR Document | 2016-10253 |
[Federal Register Volume 81, Number 85 (Tuesday, May 3, 2016)] [Notices] [Pages 26566-26569] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10253] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of New System of Records AGENCY: Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS). ACTION: Notice of New System of Records (SOR). ----------------------------------------------------------------------- SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``CMS Risk Adjustment Data Validation System (RAD-V),'' System No. 09-70-0511. Under Sec. 1343 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), (hereinafter, the ACA), and the implementing regulations at 45 CFR part 153, data collected and maintained in this system will be used to support the audit functions of the risk adjustment [[Page 26567]] program, including validation activities under the risk adjustment data validation program. The goal of the risk adjustment program is to provide payments to non-grandfathered health insurance issuers in the individual and small group markets that attract higher-risk populations, including a validation program to ensure the reliability of data used as a basis for risk adjustment payments and charges. Non-grandfathered plans are health plans that came into existence after March 23, 2010. Insurers offering these plans were required to modify them to follow the ACA rules as of January 1, 2014. The RAD-V system will contain personally identifiable information (PII) about individuals who are current or former enrollees in non- grandfathered health plans, including information obtained through the risk adjustment data validation process to establish the relative deviation from the average. The program and the system of record are more thoroughly described in the SUPPLEMENTARY INFORMATION section and System of Records Notice below. At this time, the only personally identifiable information that will be collected under this System will be through the RAD-V, part of the risk adjustment program. DATES: This action will be effective without further notice 30 days after publication in the Federal Register or 40 days after providing a report of this Notice to the Office of Management and Budget and Congress, whichever is later. Written comments should be submitted within 30 days of publication in the Federal Register. HHS may publish an amended system of records notice (SORN) in light of any comments received. ADDRESSES: Written comments can be sent to: CMS Privacy Act Officer, Division of Security, Privacy Policy & Governance, Information Security & Privacy Group, Office of Enterprise Information, CMS, 7500 Security Boulevard, Baltimore, MD 21244-1870, Mailstop: N1-24-08, or by E-Mail to: [email protected]. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9:00 a.m.-3:00 p.m., Eastern Time zone. FOR INFORMATION CONTACT: Catherine Anderson, RAD-V Mailbox Coordinator, Division of Risk Adjustment Operations, CCIIO, CMS, 7500 Security Boulevard, Baltimore, Maryland 21244. The email address is [email protected]. SUPPLEMENTARY INFORMATION: Section 1343(b) of the ACA requires the Secretary to establish criteria and methods to carry out a risk adjustment program. Section 1321(a)(1)(C) of the ACA directs the Secretary to issue regulations and set standards to establish the risk adjustment program. Consistent with Sec. 1321(c)(1) of the ACA, 45 CFR 153.310(a) provides that HHS will operate risk adjustment where a State does not elect to administer the risk adjustment program. The primary goals of the risk adjustment program are to assist health plans that provide coverage to individuals with higher health care costs and will help ensure that those who are sick have access to the coverage they need. The ACA's risk adjustment program also serves to level the playing field inside and outside of the individual and small group markets in each state by stabilizing premiums. Under 45 CFR 153.620(b), issuers of risk adjustment covered plans must maintain documents and records to enable such evaluation, and must make such records available to HHS upon request for purposes of verification, investigation, audit or other review. As part of the risk adjustment data validation program, HHS may audit an issuer of a risk adjustment covered plan to assess its compliance with the risk adjustment requirements. The state, or HHS on behalf of the state, must ensure proper validation of a statistically valid sample of risk adjustment data from each issuer that offers at least one risk adjustment covered plan in that state, as well as an administrative process to appeal findings from the risk adjustment data validation process. When HHS is conducting the risk adjustment data validation program, 45 CFR 153.620(a) and 153.630(a), requires issuers of risk adjustment covered plans to comply with any request for data for any audit or validation preformed, including relevant source enrollment documentation, all claims and encounter data, and medical record documentation. Existing information privacy and security standards, such as standards under HIPAA and those detailed at 45 CFR 153.630(f)(2), which governs the risk adjustment data validation program, will apply to issuers and their initial validation auditors. In order to minimize the amount of individually identifiable information collected, CMS will use the smallest possible sample size that will provide a statistically valid sample, in accordance with the regulations at 45 CFR 153.350(a). The Privacy Act The Privacy Act governs the collection, maintenance, use, and dissemination of certain information about individuals by agencies of the federal government. A system of records is a group of any records under the control of a federal agency from which information about individuals is retrieved by name or other personal identifier. The Privacy Act requires each agency to publish notice in the Federal Register of the existence and character of each system of records that the agency maintains, including the name and location of the system; the categories of individuals whom records are maintained; the categories, routine uses, and sources of the records; the agencies policies and practices regarding storage retrieval, access controls, and retention and disposal of the records; and the title and business address of the agency official to contact with notification, access, and amendment requests. SYSTEM NUMBER: 09-70-0511. SYSTEM NAME: Risk Adjustment Data Validation System (RAD-V), HHS/CMS/CCIIO. SECURITY CLASSIFICATION: Unclassified. SYSTEM LOCATION: The RAD-V will be physically located at the CMS Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, MD 21244- 1850, and at various contractor sites. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: The system will contain information about individuals currently or previously enrolled in a risk adjustment covered plan as defined at 45 CFR 153.20, and individual providers of medical or health care services. CATEGORIES OF RECORDS IN THE SYSTEM: CMS will collect demographic, geographic, medical and/or health care information, date of birth, gender, dates of service about individuals that are currently and previously enrolled in risk adjustment covered plans. In addition, CMS will collect identifiable information about individual health care providers, including but not limited to name, ITIN or EIN, and NPI numbers. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Authority for the maintenance of the RAD-V is given under the provisions of Sec. Sec. 1321 and 1343 of the Patient [[Page 26568]] Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), and the Regulations at 45 CFR 153.350, 153.620, 153.630. PURPOSE(S) OF THE SYSTEM: The primary purpose of this system is to collect and maintain necessary to support the audit functions of the risk adjustment programs, including validation activities under the risk adjustment data validation system (RAD-V). ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: A. Entities Who May Receive Disclosures under Routine Uses Records about an individual may be disclosed from this system of records to the following parties outside the agency, without the individual's consent, for these purposes: 1. To CMS contractors who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. 2. To a health insurance issuer participating in the risk adjustment data validation program or any agent, contractor, sub- contractor or entity of that health insurance issuer that has entered into an agreement or contract with the issuer to assist in compliance with the risk adjustment data validation program. 3. The Department of Justice (DOJ), a court or an adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his/her official capacity, or c. Any employee of the agency in his/her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, a court or an adjudicatory body is compatible for the purpose for which the agency collected the records. 4. To a CMS contractor that assists in the administration of a CMS administered health benefits program, when disclosure is deemed reasonably necessary by CMS, to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such program. 5. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate, potential fraud in the health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such program. 6. To appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, if the information disclosed is relevant to and necessary for that assistance; and information from this system may become available to U.S. Department of Homeland Security (DHS) cyber security personnel if captured in an intrusion detection system used by HHS and DHS pursuant to a DHS cyber security program that monitors internet traffic to and from federal government computer networks to prevent a variety of types of cybersecurity incidents. Records may also be disclosed to parties outside the agency, without the individual's consent, for any of the purposes authorized directly in the Privacy Act at 5 U.S.C Sec. 552(a)(b)(1), (2) and (b)(4)-(b)(12). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM STORAGE: Archived records for the risk adjustment data validation program will be stored in electronic form in the HHS-RADV Audit Tool maintained in the Acumen Web Portal. RETRIEVABILITY: The data collected is retrieved by the name of an individual, or by some other identifying number, symbol, or other identifying particular assigned to an individual. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the RAD-V have been trained in the Privacy Act information privacy and security requirements. Employees who maintain records in this system are instructed not to release data unless the intended recipient agrees to implement appropriate physical, technical, and administrative safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems, and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulation and Federal, HHS and CMS policies and standards as they relate to information security and data privacy. These laws and regulation mat apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the e-Government Act of 2002; the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and their corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III Security of Federal Automated Information Resources also applies, as well as Federal, HHS, and CMS information system security and privacy policies. RETENTION AND DISPOSAL: Records will be maintained until they become inactive, at which time they will be retired or destroyed in accordance with published records schedules of CMS, as approved by the National Archives and Records Administration, and following the guidelines in National Institutes of Science and Technology (NIST) Special Publication 800-88, Guidelines for Media Sanitation. Enrollee claims records subject to a document preservation order will be preserved consistent with the terms of the court's order. SYSTEM MANAGER AND ADDRESS: Director, Division of Risk Adjustment Operations, Payment Policy & Financial Management Group, CCIIO, CMS, 7500 Security Boulevard, Baltimore, MD 21244. NOTIFICATION PROCEDURE: Individuals wishing to know if this system contains records about them should write to the System Manager and include pertinent personally identifiable information (which CMS recommends be encrypted and properly transmitted) to be used for retrieval of their records. RECORD ACCESS PROCEDURE: Individuals seeking access to records about them in this system should follow the same instructions indicated under ``Notification Procedure'' and reasonably specify the record content being sought. (These procedures are in accordance with HHS regulations at 45 CFR 5b.5(a)(2).) [[Page 26569]] CONTESTING RECORD PROCEDURES: Individuals seeking to contest the content of information about them in this system should follow the same instructions indicated under ``Notification Procedure.'' The request should: Reasonably identify the record and specify the information being contested; state the corrective action sought; and provide the reasons for the correction, with supporting justification. (These procedures are in accordance with HHS regulations at 45 CFR 5b.7.) RECORD SOURCE CATEGORIES: The RAD-V will contain individually identifiable enrollment and demographic information, claims and encounter information and enrollees' medical records provided by issuers of risk adjustment covered plans. The issuers will provide the information as requested by CMS or a contractor on CMS' behalf. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. Dated: April 26, 2016. Emery Csulak, CMS Senior Official for Privacy, Centers for Medicare & Medicaid Services. [FR Doc. 2016-10253 Filed 5-2-16; 8:45 am] BILLING CODE 4120-03-P
![26566 Federal Register / Vol. 81, No. 85 / Tuesday, May 3, 2016 / Notices
II. Provisions of the Notice An individual or entity shall not be • Phase 2
deemed ineligible because the ++ Ease in which a user can navigate
A. Subject of Challenge Competition:
individual or entity used federal Usability and Design;
MIPS Mobile Challenge
facilities or consulted with federal ++ Evidence of design with User
1. Eligibility Rules for Participating in employees during a competition if the feedback;
the Competition facilities and employees are made ++ Innovation in Design;
To be eligible to win a prize under available to all individuals and entities ++ Functionality/Accuracy; and
this challenge, participants (individual participating in the competition on an ++ Look and Feel.
or entity) must comply with each and equitable basis.
Challenge participants will sign a C. Additional Information
every rule set forth in this section:
1. Shall register to participate in the liability release as part of the contest Challenge participants will draw from
competition under the rules registration process. The liability release existing information provided on
promulgated below by the Department will use the following language: www.cms.gov and collaborate directly
of Health and Human Services (HHS). By participating in this competition, I with health professionals and/or end
2. In the case of a private entity, shall agree to assume any and all risks and users to build their application. The
be incorporated in and maintain a waive claims against the federal participants will have access to
primary place of business in the United government and its related entities, www.cms.gov and to end users.
States, and in the case of an individual, except in the case of willing Challenge details and registration are
whether participating individually or in misconduct, for any injury, death, located at www.challenge.gov.
a group, shall be a citizen or permanent damage, or loss of property, revenue, or III. Collection of Information
resident of the United States. profits, whether direct, indirect, or Requirements
3. HHS Employees may participate in consequential, arising from my
the MIPS Mobile Challenge, but may not participation in this prize contest, This document does not impose
submit in the scope of their employment whether the injury, death, damage, or information collection requirements,
and may not pursue an application loss arises through negligence or that is, reporting, recordkeeping or
while in the federal workplace or while otherwise. third-party disclosure requirements.
on duty. Consequently, there is no need for
4. Shall not be an employee of the B. Registration Process for Participants review by the Office of Management and
CMS. 1. Amount of the Prize Budget under the authority of the
5. Federal grantees may not use Paperwork Reduction Act of 1995 (44
federal funds to develop the America The top 3 to 5 winners for phase I of U.S.C. 3501 et seq.).
COMPETES Reauthorization Act of 2010 the challenge will be provided a
monetary cash prize totaling $10,000 Dated: April 20, 2016.
(Pub. L. 111–358, enacted January 4, Andrew M. Slavitt,
2011) (COMPETES Act) challenge per winner. The Phase II final challenge
winner will be provided a monetary Acting Administrator, Centers for Medicare
applications unless consistent with the & Medicaid Services.
purpose of their grant award. cash prize totaling $25,000.
[FR Doc. 2016–10301 Filed 5–2–16; 8:45 am]
6. Federal contractors may not use 2. How Winners Are Selected
federal funds from a contract to develop BILLING CODE 4120–01–P
COMPETES Act challenge applications Challenge submissions will be judged
or to fund efforts in support of a by a panel selected by CMS with
relevant expertise in current CMS DEPARTMENT OF HEALTH AND
COMPETES Act challenge submission.
7. Applicants must agree to provide reporting systems. The expert panel of HUMAN SERVICES
the federal government an irrevocable, judges, qualified by training and
experience, will evaluate the Centers for Medicare & Medicaid
royalty-free, non-exclusive worldwide Services
license in the winning work(s) or submissions on the criteria identified
component parts thereof, in the event below in this section. Judges will be fair
Privacy Act of 1974; Report of New
that they are prize winner(s). HHS shall and impartial, may not have a personal
System of Records
be granted the rights to reproduce, or financial interest in, or be an
distribute copies to the public, publicly employee, officer, director, or agent of, AGENCY: Department of Health and
display, create derivative works, and any entity that is a registered participant Human Services (HHS), Centers for
publicly post, link to, and share the in the competition, and may not have a Medicare & Medicaid Services (CMS).
winning work(s) or parts thereof. personal or financial relationship with ACTION: Notice of New System of
A submission may be disqualified if, an individual who is a registered Records (SOR).
in CMS’s sole judgment: contestant. The panel will provide
• Fails to function as expressed in the expert advice on the merits of each SUMMARY: In accordance with the
detailed description, submission to CMS officials responsible requirements of the Privacy Act of 1974,
• The detailed description is for final selections for award. Awardees we are proposing to establish a new
significantly inaccurate or incomplete, will be notified on or around the dates SOR titled, ‘‘CMS Risk Adjustment Data
or listed in the ‘‘Date’’ section. Winners Validation System (RAD–V),’’ System
• Malware or other security threats will be selected based on the following No. 09–70–0511. Under § 1343 of the
are present. Patient Protection and Affordable Care
asabaliauskas on DSK3SPTVN1PROD with NOTICES
criteria:
Participants agree that we may Act (Pub. L. 111–148) as amended by
conduct testing on the submitted code • Phase 1 the Health Care and Education
to determine whether malware or other ++ Ease in which a user can navigate Reconciliation Act of 2010 (Pub. L. 111–
security threats may be present such Usability and Design; 152), (hereinafter, the ACA), and the
that they may damage the equipment or ++ Evidence of design with User implementing regulations at 45 CFR part
operating environments of the Federal feedback; 153, data collected and maintained in
Government or those acting on its ++ Innovation in Design; and this system will be used to support the
behalf. ++ Look and Feel. audit functions of the risk adjustment
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![Federal Register / Vol. 81, No. 85 / Tuesday, May 3, 2016 / Notices 26569
CONTESTING RECORD PROCEDURES: Dated: April 26, 2016. and renovation of child care facilities. A
Individuals seeking to contest the Emery Csulak, tribal grantee must first request and
content of information about them in CMS Senior Official for Privacy, Centers for receive approval from the
this system should follow the same Medicare & Medicaid Services. Administration for Children and
instructions indicated under [FR Doc. 2016–10253 Filed 5–2–16; 8:45 am] Families (ACF) before using CCDF funds
‘‘Notification Procedure.’’ The request BILLING CODE 4120–03–P for construction or major renovation.
should: Reasonably identify the record This information collection contains the
and specify the information being statutorily-mandated uniform
contested; state the corrective action DEPARTMENT OF HEALTH AND procedures for the solicitation and
sought; and provide the reasons for the HUMAN SERVICES consideration of requests, including
correction, with supporting justification.
Administration for Children and instructions for preparation of
(These procedures are in accordance
Families environmental assessments in
with HHS regulations at 45 CFR 5b.7.)
conjunction with the National
RECORD SOURCE CATEGORIES: Submission for OMB Review; Environmental Policy Act. The
The RAD–V will contain individually Comment Request proposed draft procedures update the
identifiable enrollment and procedures that were originally issued
demographic information, claims and Title: Procedures for Requests from
in August 1997 and last updated in
encounter information and enrollees’ Tribal Lead Agencies to use Child Care
April 2013. Respondents will be CCDF
medical records provided by issuers of and Development Fund (CCDF) Funds
for Construction or Major Renovation of tribal grantees requesting to use CCDF
risk adjustment covered plans. The funds for construction or major
issuers will provide the information as Child Care Facilities.
OMB No.: 0970–0160. renovation.
requested by CMS or a contractor on
Description: The Child Care and Respondents: Tribal Child Care Lead
CMS’ behalf.
Development Block Grant Act, as Agencies acting on behalf of Tribal
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS amended, allows Indian Tribes to use Governments.
OF THE ACT: Child Care and Development Fund
None. (CCDF) grant awards for construction
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Construction or Major Renovation of Tribal Child Care Facilities ................... 5 1 20 100
Estimated Total Annual Burden the Administration for Children and information, including each proposed
Hours: 100. Families. extension of an existing collection of
Additional Information: Copies of the information, and to allow 60 days for
Robert Sargis,
proposed collection may be obtained by public comment in response to the
Reports Clearance Officer. notice. This notice solicits comments on
writing to the Administration for [FR Doc. 2016–10293 Filed 5–2–16; 8:45 am] the information collection requirements
Children and Families, Office of BILLING CODE 4184–01–P relating to an extension with no changes
Planning, Research and Evaluation, 330
of a currently approved collection of the
C Street, Washington, DC 20201, Attn: Title III and VII State Program Report.
ACF Reports Clearance Officer. Email DEPARTMENT OF HEALTH AND
DATES: Submit written or electronic
address: infocollection@acf.hhs.gov. All HUMAN SERVICES
comments on the collection of
requests should be identified by the title
Administration for Community Living information by July 5, 2016.
of the information collection.
ADDRESSES: Submit electronic
OMB Comment: OMB is required to Agency Information Collection comments on the collection of
make a decision concerning the Activities; Proposed Extension With information to: Elena.Fazio@
collection of information between 30 No Changes of a Currently Approved acl.hhs.gov.
and 60 days after publication of this Collection; Comment Request; State Submit written comments on the
document in the Federal Register. Program Report collection of information to: U.S.
Therefore, a comment is best assured of Department of Health and Human
having its full effect if OMB receives it AGENCY: Administration for Community Services: Administration for
Living, HHS. Community Living, Washington, DC
within 30 days of publication. Written
comments and recommendation for the ACTION: Notice. 20201, Attention: Elena Fazio.
proposed information collection should SUMMARY: The Administration for FOR FURTHER INFORMATION CONTACT:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
be sent directly to the following: Office Community Living (ACL) is announcing Elena Fazio by telephone: (202) 795–
of Management and Budget, Paperwork an opportunity for public comment on 7343 or by email: Elena.Fazio@
Reduction Project, Fax: 202–395–7285, the proposed collection of certain acl.hhs.gov.
Email: OIRA_SUBMISSION@ information by the agency. Under the SUPPLEMENTARY INFORMATION: Under the
OMB.EOP.GOV, Attn: Desk Officer for Paperwork Reduction Act of 1995 (the PRA (44 U.S.C. 3501–3520), Federal
PRA), Federal agencies are required to agencies must obtain approval from the
publish notice in the Federal Register Office of Management and Budget
concerning each proposed collection of (OMB) for each collection of
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Document Created: 2016-05-03 00:30:45
Document Modified: 2016-05-03 00:30:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of New System of Records (SOR). | |
| Dates | This action will be effective without further notice 30 days after publication in the Federal Register or 40 days after providing a report of this Notice to the Office of Management and Budget and Congress, whichever is later. Written comments should be submitted within 30 days of publication in the Federal Register. HHS may publish an amended system of records notice (SORN) in light of any comments received. | |
| FR Citation | 81 FR 26566 |
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