81 FR 27450 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 88 (May 6, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 88 (May 6, 2016)
| Page Range | 27450-27452 | |
| FR Document | 2016-10705 |
[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)] [Notices] [Pages 27450-27452] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10705] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10185 and CMS-10328] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. 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 (the PRA), federal agencies are require; 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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. DATES: Comments must be received by July 5, 2016. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the [[Page 27451]] instructions for ``Comment or Submission'' or ``More Search Options'' to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. 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: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-10185 Medicare Part D Reporting Requirements and Supporting Regulations CMS-10328 Medicare Self-Referral Disclosure Protocol Under the 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 requires federal agencies to publish a 60-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. 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part D Reporting Requirements and Supporting Regulations; Use: Data collected via Medicare Part D Reporting Requirements will be an integral resource for oversight, monitoring, compliance and auditing activities necessary to ensure quality provision of the Medicare Prescription Drug Benefit to beneficiaries. For all reporting sections, data are reported electronically to CMS. Each reporting section is reported at one of the following levels: Contract (data should be entered at the H#, S#, R#, or E# level) or Plan (data should be entered at the Plan Benefit Package (PBP level, e.g., Plan 001 for contract H#, R#, S#, or E). Sponsors should retain documentation and data records related to their data submissions. Data will be validated, analyzed, and utilized for trend reporting by the Division of Clinical and Operational Performance (DCOP) within the Medicare Drug Benefit and C & D Data Group. If outliers or other data anomalies are detected, DCOP will work in collaboration with other Divisions within CMS for follow-up and resolution. For CY2017 Reporting Requirements, the following 7 reporting sections will be reported and collected at the Contract-level or Plan-level: Enrollment and Disenrollment, Retail, Home Infusion, and Long-Term Care Pharmacy Access, Medication Therapy Management (MTM) Programs, Grievances, Improving Drug Utilization Review Controls, Coverage Determinations and Redeterminations, and Employer/Union Sponsored Sponsors. Form Number: CMS-10185 (OMB control number: 0938- 0992); Frequency: Annually and semi-annually; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 561; Total Annual Responses: 11,438; Total Annual Hours: 14,750. (For policy questions regarding this collection contact Chanelle Jones at 410-786- 8008). 2. 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 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 re vision 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 [[Page 27452]] 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: May 3, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-10705 Filed 5-5-16; 8:45 am] BILLING CODE 4120-01-P
![27450 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
services being discussed. Speakers identification (ID) cards. It prohibits Paperwork Reduction Act of 1995 (44
presenting at the MEDCAC meeting Federal agencies from accepting an U.S.C. Chapter 35).
should include a full disclosure slide as official driver’s license or ID card from Authority: 5 U.S.C. App. 2, section 10(a).
their second slide in their presentation a state unless the Department of
for financial interests (for example, type Homeland Security determines that the Dated: April 27, 2016.
of financial association—consultant, state meets these standards. Beginning Kate Goodrich,
research support, advisory board, and October 2015, photo IDs (such as a valid Director, Center for Clinical Standards and
an indication of level, such as minor driver’s license) issued by a state or Quality, Centers for Medicare & Medicaid
association <$10,000 or major territory not in compliance with the Services.
association >$10,000) as well as Real ID Act will not be accepted as [FR Doc. 2016–10716 Filed 5–5–16; 8:45 am]
intellectual conflicts of interest (for identification to enter Federal buildings. BILLING CODE 4120–01–P
example, involvement in a federal or Visitors from these states/territories will
nonfederal advisory committee that has need to provide alternative proof of
discussed the issue) that may pertain in identification (such as a valid passport) DEPARTMENT OF HEALTH AND
any way to the subject of this meeting. to gain entrance into CMS buildings. HUMAN SERVICES
If you are representing an organization, The current list of states from which a
we require that you also disclose Federal agency may accept driver’s Centers for Medicare & Medicaid
conflict of interest information for that licenses for an official purpose is found Services
organization. If you do not have a at http://www.dhs.gov/real-id- [Document Identifier: CMS–10185 and CMS–
PowerPoint presentation, you will need enforcement-brief. We recommend that 10328]
to present the full disclosure confirmed registrants arrive reasonably
information requested previously at the early, but no earlier than 45 minutes Agency Information Collection
beginning of your statement to the prior to the start of the meeting, to allow Activities: Proposed Collection;
Committee. additional time to clear security. Comment Request
The Committee will deliberate openly Security measures include the AGENCY: Centers for Medicare &
on the topics under consideration. following: Medicaid Services, HHS.
Interested persons may observe the • Presentation of government-issued
ACTION: Notice.
deliberations, but the Committee will photographic identification to the
not hear further comments during this Federal Protective Service or Guard SUMMARY: The Centers for Medicare &
time except at the request of the Service personnel. Medicaid Services (CMS) is announcing
chairperson. The Committee will also • Inspection of vehicle’s interior and an opportunity for the public to
allow a 15-minute unscheduled open exterior (this includes engine and trunk comment on CMS’ intention to collect
public session for any attendee to inspection) at the entrance to the information from the public. Under the
address issues specific to the topics grounds. Parking permits and Paperwork Reduction Act of 1995 (the
under consideration. At the conclusion instructions will be issued after the PRA), federal agencies are require; to
of the day, the members will vote and vehicle inspection. publish notice in the Federal Register
the Committee will make its • Inspection, via metal detector or concerning each proposed collection of
recommendation(s) to CMS. other applicable means, of all persons information (including each proposed
entering the building. We note that all extension or reinstatement of an existing
III. Registration Instructions
items brought into CMS, whether collection of information) and to allow
CMS’ Coverage and Analysis Group is personal or for the purpose of 60 days for public comment on the
coordinating meeting registration. While presentation or to support a proposed action. Interested persons are
there is no registration fee, individuals presentation, are subject to inspection. invited to send comments regarding our
must register to attend. You may register We cannot assume responsibility for burden estimates or any other aspect of
online at http://www.cms.gov/apps/ coordinating the receipt, transfer, this collection of information, including
events/upcomingevents.asp? transport, storage, set-up, safety, or any of the following subjects: (1) The
strOrderBy=1&type=3 or by phone by timely arrival of any personal necessity and utility of the proposed
contacting the person listed in the FOR belongings or items used for information collection for the proper
FURTHER INFORMATION CONTACT section of presentation or to support a performance of the agency’s functions;
this notice by the deadline listed in the presentation. (2) the accuracy of the estimated
DATES section of this notice. Please Note: Individuals who are not burden; (3) ways to enhance the quality,
provide your full name (as it appears on registered in advance will not be utility, and clarity of the information to
your state-issued driver’s license), permitted to enter the building and will be collected; and (4) the use of
address, organization, telephone be unable to attend the meeting. The automated collection techniques or
number(s), fax number, and email public may not enter the building earlier other forms of information technology to
address. You will receive a registration than 45 minutes prior to the convening minimize the information collection
confirmation with instructions for your of the meeting. burden.
arrival at the CMS complex or you will All visitors must be escorted in areas
be notified that the seating capacity has other than the lower and first floor DATES: Comments must be received by
been reached. levels in the Central Building. July 5, 2016.
ADDRESSES: When commenting, please
asabaliauskas on DSK3SPTVN1PROD with NOTICES
IV. Security, Building, and Parking V. Collection of Information reference the document identifier or
Guidelines This document does not impose OMB control number. To be assured
This meeting will be held in a federal information collection requirements, consideration, comments and
government building; therefore, federal that is, reporting, recordkeeping or recommendations must be submitted in
security measures are applicable. The third-party disclosure requirements. any one of the following ways:
Real ID Act, enacted in 2005, establishes Consequently, there is no need for 1. Electronically. You may send your
minimum standards for the issuance of review by the Office of Management and comments electronically to http://
state-issued driver’s licenses and Budget under the authority of the www.regulations.gov. Follow the
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![27452 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
that is required for submissions to the Pharmacy Compounding Advisory CONTACT). In light of the fact that no
SRDP and providing a streamlined and Committee. The committee is a change has been made to the committee
standardized format for the presentation discretionary Federal advisory name or description of duties, no
of the required information. Form committee established to provide advice amendment will be made to 21 CFR
Number: CMS–10328 (OMB control to the Commissioner. The Pharmacy 14.100.
number: 0938–1106); Frequency: Compounding Advisory Committee This document is issued under the
Annually and semi-annually; Affected advises the Commissioner or designee Federal Advisory Committee Act (5
Public: Private sector (Business or other in discharging responsibilities as they U.S.C. app.). For general information
for-profits and Not-for-profits); Number relate to compounded drugs for human related to FDA advisory committees,
of Respondents: 200; Total Annual use and, as required, any other product please visit us at http://www.fda.gov/
Responses: 200; Total Annual Hours: for which the Food and Drug AdvisoryCommittees/default.htm.
5,000. (For policy questions regarding Administration has regulatory Dated: April 29, 2016.
this collection contact Matt Edgar at responsibility. Jill Hartzler Warner,
410–786–0698.) The Committee shall provide advice
Associate Commissioner for Special Medical
on scientific, technical, and medical Programs.
Dated: May 3, 2016.
issues concerning drug compounding
William N. Parham, III, [FR Doc. 2016–10585 Filed 5–5–16; 8:45 am]
under sections 503A and 503B of the
Director, Paperwork Reduction Staff, Office Federal Food, Drug, and Cosmetic Act BILLING CODE 4164–01–P
of Strategic Operations and Regulatory (21 U.S.C. 353a) and (21 U.S.C. 353b),
Affairs.
and, as required, any other product for DEPARTMENT OF HEALTH AND
[FR Doc. 2016–10705 Filed 5–5–16; 8:45 am] which the Food and Drug HUMAN SERVICES
BILLING CODE 4120–01–P Administration has regulatory
responsibility, and make appropriate Health Resources and Services
recommendations to the Commissioner Administration
DEPARTMENT OF HEALTH AND of Food and Drugs.
HUMAN SERVICES The Committee shall consist of a core Agency Information Collection
of 12 voting members including the Activities: Proposed Collection: Public
Food and Drug Administration
Chair. Members and the Chair are Comment Request
[Docket No. FDA–2013–N–1687] selected by the Commissioner or
designee from among authorities AGENCY: Health Resources and Services
Advisory Committee; Pharmacy knowledgeable in the fields of Administration, HHS.
Compounding Advisory Committee, pharmaceutical compounding, ACTION: Notice.
Renewal pharmaceutical manufacturing, SUMMARY: In compliance with the
AGENCY: Food and Drug Administration, pharmacy, medicine, and related requirement for opportunity for public
HHS. specialties. These members will include comment on proposed data collection
representatives from the National projects (section 3506(c)(2)(A) of the
ACTION:Notice; renewal of advisory Association of Boards of Pharmacy, the
committee. Paperwork Reduction Act of 1995), the
United States Pharmacopeia, Health Resources and Services
SUMMARY: The Food and Drug pharmacists with current experience Administration (HRSA) announces
Administration (FDA) is announcing the and expertise in compounding, plans to submit an Information
renewal of the Pharmacy Compounding physicians with background and Collection Request (ICR), described
Advisory Committee by the knowledge in compounding, and patient below, to the Office of Management and
Commissioner of Food and Drugs (the and public health advocacy Budget (OMB). Prior to submitting the
Commissioner). The Commissioner has organizations. Members will be invited ICR to OMB, HRSA seeks comments
determined that it is in the public to serve for overlapping terms of up to from the public regarding the burden
interest to renew the Pharmacy 4 years. Almost all non-Federal estimate, below, or any other aspect of
Compounding Advisory Committee for members of this committee serve as the ICR.
an additional 2 years beyond the charter Special Government Employees. The
DATES: Comments on this Information
expiration date. The new charter will be core of voting members may include one
Collection Request must be received no
in effect until April 25, 2018. or more technically qualified members,
later than July 5, 2016.
selected by the Commissioner or
DATES: Authority for the Pharmacy ADDRESSES: Submit your comments to
designee, who are identified with
Compounding Advisory Committee will consumer interests and are paperwork@hrsa.gov or mail the HRSA
expire on April 25, 2016, unless the recommended by either a consortium of Information Collection Clearance
Commissioner formally determines that consumer-oriented organizations or Officer, Room 14N–39, Parklawn
renewal is in the public interest. other interested persons. In addition to Building, 5600 Fishers Lane, Rockville,
FOR FURTHER INFORMATION CONTACT: the voting members, the Committee may MD 20857.
Cindy Hong, Center for Drug Evaluation include one or more non-voting FOR FURTHER INFORMATION CONTACT: To
and Research, Food and Drug members who are identified with request more information on the
Administration, 10903 New Hampshire industry interests. proposed project or to obtain a copy of
Ave., Bldg. 31, Rm. 2417, Silver Spring, Further information regarding the the data collection plans and draft
asabaliauskas on DSK3SPTVN1PROD with NOTICES
MD 20993–0002, 301–796–9001, most recent charter and other instruments, email paperwork@hrsa.gov
PCAC@fda.hhs.gov. information can be found at http:// or call the HRSA Information Collection
SUPPLEMENTARY INFORMATION: Pursuant www.fda.gov/AdvisoryCommittees/ Clearance Officer at (301) 443–1984.
to 41 CFR 102–3.65 and approval by the CommitteesMeetingMaterials/Drugs/ SUPPLEMENTARY INFORMATION: When
Department of Health and Human PharmacyCompoundingAdvisory submitting comments or requesting
Services pursuant to 45 CFR part 11 and Committee/ucm381305.htm or by information, please include the
by the General Services Administration, contacting the Designated Federal information request collection title for
FDA is announcing the renewal of the Officer (see FOR FURTHER INFORMATION reference.
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Document Created: 2016-05-06 00:29:30
Document Modified: 2016-05-06 00:29:30
| 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 must be received by July 5, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 27450 |
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