80 FR 63561 - Agency Information Collection Activities; Proposed Collection; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 202 (October 20, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 202 (October 20, 2015)
| Page Range | 63561-63562 | |
| FR Document | 2015-26604 |
[Federal Register Volume 80, Number 202 (Tuesday, October 20, 2015)] [Notices] [Pages 63561-63562] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26604] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: HHS-OS-0945-0002-60D] Agency Information Collection Activities; Proposed Collection; Public Comment Request AGENCY: Office of the Secretary, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0945-0002, which expires on 12/31/2015. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on the ICR must be received on or before December 21, 2015. ADDRESSES: Submit your comments to [email protected] or by calling (202) 690-6162. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, [email protected] or (202) 690-6162. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the document identifier HHS-OS-0945-0002- 60D for reference. Proposed Project: Complaint Forms for Discrimination; Health Information Privacy Complaints. OMB No. 0945-0002--Extension--Office of Civil Rights. Abstract: The Office for Civil Rights is seeking an extension on an approval for a 3-year clearance on a previous collection. Individuals may file written complaints with the Office for Civil Rights when they believe they have been discriminated against by programs or entities that receive Federal financial assistance from the Health and Human Service or if they believe that their right to the privacy of protected health information has been violated. Annual Number of Respondents frequency of submission is record keeping and reporting on occasion. [[Page 63562]] Estimated Annualized Burden Table ---------------------------------------------------------------------------------------------------------------- Number of Average Forms Type of Number of responses per burden hours Total burden respondent respondents respondent per response hours ---------------------------------------------------------------------------------------------------------------- Civil Rights Complaint Form... Individuals or 3493 1 45/60 2620 households, Not- for-profit institutions. Health Information Privacy Individuals or 10,286 1 45/60 7715 Complaint Form. households, Not- for-profit institutions. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 10,335 ---------------------------------------------------------------------------------------------------------------- OS specifically requests comments on (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. Darius Taylor, Information Collection Clearance Officer. [FR Doc. 2015-26604 Filed 10-19-15; 8:45 am] BILLING CODE 4153-01-P
![Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices 63561
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
Number of Total Hours per Total burden
Form name responses per
respondents responses respondent hours
respondent
Hospital Enrollment, Additions & Recertifications
340B Program Registrations & Certifications for Hospitals 194 1 194 2 388
Certifications to Enroll Hospital Outpatient Facilities ........... 697 8 5576 0.5 2788
Hospital Annual Recertifications .......................................... 2134 6 12804 0.25 3201
Registrations and Recertifications for Entities Other Than Hospitals
340B Registrations for Community Health Centers ............ 427 3 1281 1 1281
340B Registrations for STD/TB Clinics ............................... 647 1 647 1 647
340B Registrations for Various Other Eligible Entity Types 405 1 405 1 405
Community Health Center Annual Recertifications ............. 1204 5 6020 0.25 1505
STD & TB Annual Recertifications ...................................... 3123 1 3123 0.25 780.75
Annual Recertification for entities other than Hospitals,
Community Health Centers, and STD/TB Clinics ............ 4899 1 4899 0.25 1224.75
Contracted Pharmacy Services Registration & Recertifications
Contracted Pharmacy Services Registration ....................... 1758 5 8790 1 8790
Other Information Collections
Submission of Administrative Changes for any Covered
Entity ................................................................................. 9396 1 9396 0.5 4698
Submission of Administrative Changes for any Manufac-
turer .................................................................................. 350 1 350 0.5 175
Manufacturer Data Required to Verify 340B Ceiling Price
Calculations ...................................................................... 600 4 2400 0.5 1200
Pharmaceutical Pricing Agreement ..................................... 200 1 200 1 200
Pharmaceutical Pricing Agreement (PPA) Addendum ........ 620 1 620 0.5 310
Total .............................................................................. 26,554 ........................ 56,705 ........................ 27593.5
HRSA specifically requests comments ACTION: Notice. SUPPLEMENTARY INFORMATION: When
on (1) the necessity and utility of the submitting comments or requesting
proposed information collection for the SUMMARY: In compliance with section information, please include the
proper performance of the agency’s 3506(c)(2)(A) of the Paperwork document identifier HHS–OS–0945–
functions, (2) the accuracy of the Reduction Act of 1995, the Office of the 0002–60D for reference.
estimated burden, (3) ways to enhance Secretary (OS), Department of Health Proposed Project: Complaint Forms
the quality, utility, and clarity of the and Human Services, announces plans
information to be collected, and (4) the for Discrimination; Health Information
to submit an Information Collection
use of automated collection techniques Privacy Complaints.
Request (ICR), described below, to the
or other forms of information Office of Management and Budget OMB No. 0945–0002—Extension—
technology to minimize the information (OMB). The ICR is for extending the use Office of Civil Rights.
collection burden. of the approved information collection Abstract: The Office for Civil Rights is
Jackie Painter, assigned OMB control number 0945– seeking an extension on an approval for
Director, Division of the Executive Secretariat. 0002, which expires on 12/31/2015. a 3-year clearance on a previous
Prior to submitting the ICR to OMB, OS collection. Individuals may file written
[FR Doc. 2015–26522 Filed 10–19–15; 8:45 am]
seeks comments from the public complaints with the Office for Civil
BILLING CODE 4165–15–P
regarding the burden estimate, below, or Rights when they believe they have
any other aspect of the ICR. been discriminated against by programs
DEPARTMENT OF HEALTH AND DATES: Comments on the ICR must be or entities that receive Federal financial
HUMAN SERVICES received on or before December 21, assistance from the Health and Human
2015. Service or if they believe that their right
Office of the Secretary to the privacy of protected health
[Document Identifier: HHS–OS–0945–0002– ADDRESSES: Submit your comments to information has been violated. Annual
60D] Information.CollectionClearance@ Number of Respondents frequency of
mstockstill on DSK4VPTVN1PROD with NOTICES
hhs.gov or by calling (202) 690–6162.
submission is record keeping and
Agency Information Collection
FOR FURTHER INFORMATION CONTACT: reporting on occasion.
Activities; Proposed Collection; Public
Information Collection Clearance staff,
Comment Request
Information.CollectionClearance@
AGENCY: Office of the Secretary, HHS. hhs.gov or (202) 690–6162.
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![63562 Federal Register / Vol. 80, No. 202 / Tuesday, October 20, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Number of Average
Number of Total burden
Forms Type of respondent responses per burden hours
respondents hours
respondent per response
Civil Rights Complaint Form ............. Individuals or households, Not-for- 3493 1 45/60 2620
profit institutions.
Health Information Privacy Com- Individuals or households, Not-for- 10,286 1 45/60 7715
plaint Form. profit institutions.
Total ........................................... ........................................................... ........................ ........................ ........................ 10,335
OS specifically requests comments on from the official case files, which are SSA. The second level of review is
(1) the necessity and utility of the covered under other SORNs (i.e., HHS administered by OMHA and is
proposed information collection for the SORN 09–70–0566 covers case files on conducted by ALJs. Subsequent reviews
proper performance of the agency’s Medicare claims appeals, and SSA are conducted at the third level of
functions, (2) the accuracy of the SORN 60–0089 covers case files on appeal within the DAB and at the fourth
estimated burden, (3) ways to enhance Medicare entitlement appeals). level by the federal district courts.
the quality, utility, and clarity of the DATES: This system notice is effective The Department established OMHA in
information to be collected, and (4) the immediately, with the exception of the June, 2005, pursuant to section 931 of
use of automated collection techniques routine uses. The routine uses will be the Medicare Prescription Drug,
or other forms of information effective 30 days after publication, Improvement, and Modernization Act of
technology to minimize the information unless HHS receives comments that 2003 (Pub. L. 108–173) (MMA), which
collection burden. warrant a revision to this Notice. required the transfer of responsibility
ADDRESSES: Send public comments by
for the ALJ hearing function of the
Darius Taylor,
mail or email to: Andrea Monson, Medicare claims and entitlement
Information Collection Clearance Officer. appeals process from SSA to HHS. The
[FR Doc. 2015–26604 Filed 10–19–15; 8:45 am]
Director, Division of Information
Management and Systems, 1700 North MMA requires a unified case tracking
BILLING CODE 4153–01–P
Moore Street, Suite 1800, Arlington, VA system that facilitates the maintenance
22209, 703–235–0635, andrea.monson@ and transfer of case-specific data across
hhs.gov. Comments will be available for both the fee-for-service and managed
DEPARTMENT OF HEALTH AND care components of the Medicare
HUMAN SERVICES public inspection and copying at the
program. HHS’ CMS operates the
above location.
unified case tracking system required by
Office of the Secretary FOR FURTHER INFORMATION CONTACT:
MMA, which is covered by CMS System
Andrea Monson, Director, Division of of Record Notice No. 09–70–0566,
Privacy Act of 1974; System of Information Management and Systems,
Records Notice entitled ‘‘Medicare Appeals System’’
1700 North Moore Street, Suite 1800, (MAS SORN).
AGENCY: Office of the Secretary (OS), Arlington, VA 22209, 703–235–0635, OMHA’s adjudication process uses a
Department of Health and Human andrea.monson@hhs.gov. ‘‘case file’’ comprising the official
Services (HHS). SUPPLEMENTARY INFORMATION: agency record, and an ALJ working file.
ACTION: Notice to establish a new I. Background on New System of The case file will continue to be covered
Privacy Act system of records. Records by CMS’ MAS SORN for Medicare
claims appeals. The case file for
SUMMARY: In accordance with the The Medicare claims appeals process Medicare entitlement and premium
requirements of the Privacy Act of 1974, consists of four levels of administrative appeals will continue to be covered by
as amended (5 U.S.C. 552a), the Office review within HHS, and a fifth level of the SSA Claims Folders System, Social
of Medicare Hearings and Appeals review with the federal district courts Security Administration Claims Folders
(OMHA) within the Office of the after administrative remedies within System, Social Security Administration,
Secretary of Health and Human Services HHS have been exhausted. The first two Office of the General Counsel, Office of
(HHS) is establishing a new system of levels of review are administered by the Public Disclosure (60–0089). The case
records, System No. 09–90–1501, Centers for Medicare & Medicaid file is used throughout the
entitled ‘‘Administrative Law Judge Services (CMS) and conducted by administrative appeals process by the
(ALJ) Working File, Office of Medicare Medicare contractors. The third level of various levels of review.
Hearings and Appeals,’’ to cover OMHA review is administered by OMHA and is Only OMHA’s ALJ working files will
ALJ working files previously maintained conducted by ALJs. Subsequent reviews now be covered in the new system of
as part of the Social Security are conducted at the fourth level of records established by this Notice, to
Administration’s (SSA) ALJ Working appeal within the Departmental Appeals reflect that they are used only by
File system of records 60–0005 (last Board (DAB), and at the fifth level by OMHA.
published at 74 FR 19617). The working the federal district courts.
II. The Privacy Act
mstockstill on DSK4VPTVN1PROD with NOTICES
files covered under new System of The Medicare entitlement and
Records Notice (SORN) 09–90–1501 are premium appeals process consists of The Privacy Act (5 U.S.C. 552a)
created and used by OMHA ALJs and three levels of administrative review, governs the means by which the U.S.
members of their staffs for internal and a fourth level of review with the Government collects, maintains, and
purposes, to document actions taken by federal district courts after uses information about individuals in a
OMHA at the hearing level in each administrative remedies have been system of records. A ‘‘system of
Medicare appeal case that OMHA exhausted. The first level is the records’’ is a group of any records under
reviews. The working files are separate reconsideration level conducted by the control of a federal agency from
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Document Created: 2015-12-14 15:25:08
Document Modified: 2015-12-14 15:25:08
| 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. | |
| Dates | Comments on the ICR must be received on or before December 21, 2015. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-6162. | |
| FR Citation | 80 FR 63561 |
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