81 FR 62503 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 175 (September 9, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 175 (September 9, 2016)
| Page Range | 62503-62504 | |
| FR Document | 2016-21625 |
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)] [Notices] [Pages 62503-62504] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21625] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10328] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by October 11, 2016. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR Email: [email protected]. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786- 1326. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Self- Referral Disclosure Protocol; Use: The Affordable Care Act (``ACA'') was enacted on March 23, 2010. Section 6409 of the ACA requires the Secretary of the Department of Health and Human Services (the ``Secretary''), in cooperation with the Office of Inspector General of the Department of Health and Human Services, to establish a Medicare self-referral disclosure protocol (``SRDP''). The SRDP enables providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute, section 1877 of the Social Security Act (the ``Act''). Section 6409(b) of the ACA gives the Secretary the authority to reduce the amount due and owing for all violations of section 1877 of the Act. In establishing the amount by which an overpayment may be reduced, the Secretary may consider: the nature and extent of the improper or illegal practice; the timeliness of the self-disclosure; the cooperation in providing additional information related to the disclosure; and such other factors as the Secretary considers appropriate. In accordance with the ACA, CMS established the SRDP on September 23, 2010, and information concerning how [[Page 62504]] to disclose an actual or potential violation of section 1877 of the Act was posted on the CMS Web site. The most recent approval of this information collection request (``ICR'') was issued by the Office of Management and Budget on August 26, 2014. We are now seeking approval to revise the currently approved ICR. Under the currently approved collection, a party must provide a financial analysis of overpayments arising from actual or potential violations of section 1877 of the Act based on a 4-year lookback period. On February 12, 2016, CMS published a final rule on the reporting and returning of overpayments. See CMS- 6037-F, Medicare Program; Reporting and Returning of Overpayments, 81 FR 7654 (Feb. 12, 2016) (the ``final overpayment rule''). The final overpayment rule establishes a 6-year lookback period for reporting and returning overpayments. We are revising the information collection for the SRDP to reflect the 6-year lookback period established by the final overpayment rule. The revision is necessary to ensure that parties submitting self-disclosures to the SRDP report overpayments for the entire 6-year lookback period. The 6-year lookback period applies only to submissions to the SRDP received on or after March 14, 2016, the effective date of the final overpayment rule; parties submitting self- disclosures to the SRDP prior to March 14, 2016 need only provide a financial analysis of potential overpayments based on a 4-year lookback period. We are also taking the opportunity to streamline and simplify the SRDP by issuing a required form for SRDP submissions. The SRDP Form will reduce the burden on disclosing parties by reducing the amount of information that is required for submissions to the SRDP and providing a streamlined and standardized format for the presentation of the required information. Form Number: CMS-10328 (OMB control number: 0938- 1106); Frequency: Annually and semi-annually; Affected Public: Private sector (Business or other for-profits and Not-for-profits); Number of Respondents: 200; Total Annual Responses: 200; Total Annual Hours: 5,000. (For policy questions regarding this collection contact Matt Edgar at 410-786-0698). Dated: September 2, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-21625 Filed 9-8-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices 62503
whether such items are in written form, DEPARTMENT OF HEALTH AND and CMS document identifier, to
in the form of computer data, or in any HUMAN SERVICES Paperwork@cms.hhs.gov.
other form, for a period of three years 3. Call the Reports Clearance Office at
after final payment. This information is Centers for Medicare & Medicaid (410) 786–1326.
necessary for examination and audit of Services FOR FURTHER INFORMATION CONTACT:
contract surveillance, verification of [Document Identifier: CMS–10328] Reports Clearance Office at (410) 786–
contract pricing, and to provide 1326.
reimbursement of contractor costs, Agency Information Collection SUPPLEMENTARY INFORMATION: Under the
where applicable. The records retention Activities: Submission for OMB Paperwork Reduction Act of 1995 (PRA)
period is required by the statutory Review; Comment Request (44 U.S.C. 3501–3520), federal agencies
authorities at 10 U.S.C. 2313, 41 U.S.C. must obtain approval from the Office of
AGENCY: Centers for Medicare &
254, and 10 U.S.C. 2306, and are Management and Budget (OMB) for each
Medicaid Services.
implemented through the following collection of information they conduct
ACTION: Notice.
clauses: Audit and Records-Negotiation or sponsor. The term ‘‘collection of
clause, 52.215–2; Contract Terms and SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
Conditions Required to Implement Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and
Statutes or Executive Orders- an opportunity for the public to includes agency requests or
Commercial Items clause, 52.212–5; and comment on CMS’ intention to collect requirements that members of the public
Audit and Records-Sealed Bidding information from the public. Under the submit reports, keep records, or provide
clause, 52.214–26. This information Paperwork Reduction Act of 1995 information to a third party. Section
collection does not require contractors (PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
to create or maintain any records that publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
the contractor does not normally concerning each proposed collection of to publish a 30-day notice in the
maintain in its usual course of business. information, including each proposed Federal Register concerning each
extension or reinstatement of an existing proposed collection of information,
B. Annual Reporting Burden collection of information, and to allow including each proposed extension or
Respondents: 14,830. a second opportunity for public reinstatement of an existing collection
comment on the notice. Interested of information, before submitting the
Responses per Respondent: 10. persons are invited to send comments collection to OMB for approval. To
Total number of responses: 148,300. regarding the burden estimate or any comply with this requirement, CMS is
Hours per Response: 1.0. other aspect of this collection of publishing this notice that summarizes
information, including any of the the following proposed collection(s) of
Total Burden Hours: 148,300. following subjects: The necessity and information for public comment:
C. Public Comments utility of the proposed information 1. Type of Information Collection
collection for the proper performance of Request: Revision of a currently
Public comments are particularly the agency’s functions; the accuracy of approved collection; Title of
invited on: Whether this collection of the estimated burden; ways to enhance Information Collection: Medicare Self-
information is necessary for the proper the quality, utility, and clarity of the Referral Disclosure Protocol; Use: The
performance of functions of the Federal information to be collected; and the use Affordable Care Act (‘‘ACA’’) was
Acquisition Regulation (FAR), and of automated collection techniques or enacted on March 23, 2010. Section
whether it will have practical utility; other forms of information technology to 6409 of the ACA requires the Secretary
whether our estimate of the public minimize the information collection of the Department of Health and Human
burden of this collection of information burden. Services (the ‘‘Secretary’’), in
is accurate, and based on valid DATES: Comments on the collection(s) of cooperation with the Office of Inspector
assumptions and methodology and ways information must be received by the General of the Department of Health and
to enhance the quality, utility, and OMB desk officer by October 11, 2016. Human Services, to establish a Medicare
clarity of the information to be ADDRESSES: When commenting on the self-referral disclosure protocol
collected. proposed information collections, (‘‘SRDP’’). The SRDP enables providers
Obtaining Copies of Proposals: please reference the document identifier of services and suppliers to self-disclose
Requesters may obtain a copy of the or OMB control number. To be assured actual or potential violations of the
information collection documents from consideration, comments and physician self-referral statute, section
the General Services Administration, recommendations must be received by 1877 of the Social Security Act (the
Regulatory Secretariat Division (MVCB), the OMB desk officer via one of the ‘‘Act’’). Section 6409(b) of the ACA
1800 F Street NW., Washington, DC following transmissions: OMB, Office of gives the Secretary the authority to
20405, telephone 202–501–4755. Please Information and Regulatory Affairs, reduce the amount due and owing for
cite OMB Control Number 9000–0034, Attention: CMS Desk Officer, Fax all violations of section 1877 of the Act.
Examination of Records by Comptroller Number: (202) 395–5806 OR Email: In establishing the amount by which an
General and Contract Audit, in all OIRA_submission@omb.eop.gov. overpayment may be reduced, the
correspondence. To obtain copies of a supporting Secretary may consider: the nature and
extent of the improper or illegal
asabaliauskas on DSK3SPTVN1PROD with NOTICES
statement and any related forms for the
Dated: September 6, 2016.
proposed collection(s) summarized in practice; the timeliness of the self-
Lorin S. Curit, this notice, you may make your request disclosure; the cooperation in providing
Director, Federal Acquisition Policy, Office using one of following: additional information related to the
of Government-wide Acquisition Policy, 1. Access CMS’ Web site address at disclosure; and such other factors as the
Office of Acquisition Policy, Office of http://www.cms.hhs.gov/Paperwork Secretary considers appropriate.
Government-wide Policy. ReductionActof1995. In accordance with the ACA, CMS
[FR Doc. 2016–21721 Filed 9–8–16; 8:45 am] 2. Email your request, including your established the SRDP on September 23,
BILLING CODE 6820–EP–P address, phone number, OMB number, 2010, and information concerning how
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![62504 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
to disclose an actual or potential DEPARTMENT OF HEALTH AND available via Webcast. The Webcast will
violation of section 1877 of the Act was HUMAN SERVICES be available at the following link for
posted on the CMS Web site. The most both days: https://collaboration.fda.gov/
recent approval of this information Food and Drug Administration bpac1116/.
collection request (‘‘ICR’’) was issued by [Docket No. FDA–2016–N–0001] SUPPLEMENTARY INFORMATION:
the Office of Management and Budget Agenda: On the morning of November
on August 26, 2014. Blood Products Advisory Committee 17, 2016, the Committee will meet in
We are now seeking approval to revise Advisory Committee; Notice of Meeting open session to discuss strategies to
the currently approved ICR. Under the manage iron deficiency associated with
currently approved collection, a party AGENCY: Food and Drug Administration,
blood donation. The Committee will
must provide a financial analysis of HHS.
also discuss proposed procedures for
overpayments arising from actual or ACTION: Notice. assuring donor safety for collections of
potential violations of section 1877 of blood from female donors with
the Act based on a 4-year lookback SUMMARY: The Food and Drug
Administration (FDA) announces a hemoglobin values of 12.0–12.4g/dL or
period. On February 12, 2016, CMS a hematocrit value between 36 and 38.
published a final rule on the reporting forthcoming public advisory committee
meeting of the Blood Products Advisory In the afternoon, the Committee will
and returning of overpayments. See meet in open session to discuss adverse
CMS- 6037–F, Medicare Program; Committee. The general function of the
committee is to provide advice and reactions related to blood donation in
Reporting and Returning of teenage (16 to 18 years) donors, and the
Overpayments, 81 FR 7654 (Feb. 12, recommendations to the Agency on
FDA’s regulatory issues. The meeting effectiveness of several mitigation
2016) (the ‘‘final overpayment rule’’). measures. On November 18, 2016, the
The final overpayment rule establishes will be open to the public.
Committee will meet in open session to
a 6-year lookback period for reporting DATES: The meeting will be held on
hear an informational session on Zika
and returning overpayments. We are November 17, 2016, from 8 a.m. to 5:30
virus and blood safety in the United
revising the information collection for p.m. and on November 18, 2016, from
States. Following the informational
the SRDP to reflect the 6-year lookback 8:30 a.m. to 1 p.m.
session, the Committee will hear
period established by the final ADDRESSES: FDA White Oak Campus, presentations on the following topics:
overpayment rule. The revision is 10903 New Hampshire Ave., Building (1) The Transfusion Transmissible
necessary to ensure that parties 31 Conference Center, the Great Room Infections Monitoring System; (2) a
submitting self-disclosures to the SRDP (Rm. 1503), Silver Spring, MD, 20993– summary of the FDA workshop on new
report overpayments for the entire 6- 0002. Answers to commonly asked methods to predict the immunogenicity
year lookback period. The 6-year questions including information of therapeutic coagulation proteins; and
lookback period applies only to regarding special accommodations due (3) a summary of the FDA workshop on
submissions to the SRDP received on or to a disability, visitor parking, and preclinical evaluation of red blood cells
after March 14, 2016, the effective date transportation may be accessed at: for transfusion.
of the final overpayment rule; parties http://www.fda.gov/ FDA intends to make background
submitting self-disclosures to the SRDP AdvisoryCommittees/ material available to the public no later
prior to March 14, 2016 need only AboutAdvisoryCommittees/ than 2 business days before the meeting.
provide a financial analysis of potential ucm408555.htm. If FDA is unable to post the background
overpayments based on a 4-year FOR FURTHER INFORMATION CONTACT: material on its Web site prior to the
lookback period. LCDR Bryan Emery or Joanne Lipkind, meeting, the background material will
We are also taking the opportunity to Division of Scientific Advisors and be made publicly available at the
streamline and simplify the SRDP by Consultants, Center for Biologics location of the advisory committee
issuing a required form for SRDP Evaluation and Research, Food and meeting, and the background material
submissions. The SRDP Form will Drug Administration, 10903 New will be posted on FDA’s Web site after
reduce the burden on disclosing parties Hampshire Ave., Silver Spring, MD the meeting. Background material is
by reducing the amount of information 20993–0002, Bldg. 71, Rm. 6132, at 240– available at http://www.fda.gov/
that is required for submissions to the 402–8054, bryan.emery@fda.hhs.gov AdvisoryCommittees/Calendar/
SRDP and providing a streamlined and and 240–402–8106, joanne.lipkind@ default.htm. Scroll down to the
standardized format for the presentation fda.hhs.gov, respectively, or FDA appropriate advisory committee meeting
of the required information. Form Advisory Committee Information Line, link.
Number: CMS–10328 (OMB control 1–800–741–8138 (301–443–0572 in the Procedure: Interested persons may
number: 0938–1106); Frequency: Washington, DC area). A notice in the present data, information, or views,
Annually and semi-annually; Affected Federal Register about last minute orally or in writing, on issues pending
Public: Private sector (Business or other modifications that impact a previously before the committee. Written
for-profits and Not-for-profits); Number announced advisory committee meeting submissions may be made to the contact
of Respondents: 200; Total Annual cannot always be published quickly person on or before November 4, 2016.
Responses: 200; Total Annual Hours: enough to provide timely notice. Oral presentations from the public will
5,000. (For policy questions regarding Therefore, you should always check the be scheduled between approximately 11
this collection contact Matt Edgar at Agency’s Web site at http:// a.m. to 11:45 a.m. and 4 p.m. to 4:30
asabaliauskas on DSK3SPTVN1PROD with NOTICES
410–786–0698). www.fda.gov/AdvisoryCommittees/ p.m. on November 17, 2016. Oral
Dated: September 2, 2016. default.htm and scroll down to the presentations from the public will also
William N. Parham, III, appropriate advisory committee meeting be scheduled between approximately
Director, Paperwork Reduction Staff, Office link, or call the advisory committee 10:30 a.m. and 11 a.m. and 12:30 p.m.
of Strategic Operations and Regulatory information line to learn about possible to 1 p.m. on November 18, 2016. Those
Affairs. modifications before coming to the individuals interested in making formal
[FR Doc. 2016–21625 Filed 9–8–16; 8:45 am] meeting. For those unable to attend in oral presentations should notify the
BILLING CODE 4120–01–P person, the meeting will also be contact person and submit a brief
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Document Created: 2018-02-09 13:14:58
Document Modified: 2018-02-09 13:14:58
| 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 collection(s) of information must be received by the OMB desk officer by October 11, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 62503 |
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