83 FR 12951 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 58 (March 26, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 58 (March 26, 2018)
| Page Range | 12951-12952 | |
| FR Document | 2018-06052 |
[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)] [Notices] [Pages 12951-12952] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06052] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10249 and CMS-10261] 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 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 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 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 must be received by May 25, 2018. 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 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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 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: William Parham at (410) 786-4669. 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 [[Page 12952]] and associated materials (see ADDRESSES). CMS-10249 Administrative Requirements for Section 6071 of the Deficit Reduction Act CMS-10261 Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a) 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. Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Administrative Requirements for Section 6071 of the Deficit Reduction Act; Use: State Operational Protocols should provide enough information such that: The CMS Project Officer and other federal officials may use it to understand the operation of the demonstration, prepare for potential site visits without needing additional information, or both; the State Project Director can use it as the manual for program implementation; and external stakeholders may use it to understand the operation of the demonstration. The financial information collection is used in our financial statements and shared with the auditors who validate CMS' financial position. The Money Follows the Person Rebalancing Demonstration (MFP) Finders File, MFP Program Participation Data file, and MFP Services File are used by the national evaluation contractor to assess program outcomes while we use the information to monitor program implementation. The MFP Quality of Life data is used by the national evaluation contractor to assess program outcomes. The evaluation is used to determine how participants' quality of life changes after transitioning to the community. The semi-annual progress report is used by the national evaluation contractor and CMS to monitor program implementation at the grantee level. Form Number: CMS-10249 (OMB control number: 0938-1053); Frequency: Yearly, quarterly, and semi- annually; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 45; Total Annual Responses: 28,590; Total Annual Hours: 14,225. (For policy questions regarding this collection contact Effie George at 410-786-8639.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Part C Medicare Advantage Reporting Requirements and Supporting Regulations in 42 CFR 422.516(a); Use: Medicare Advantage Organizations (MAOs) must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, and while safeguarding the confidentiality of the doctor-patient relationship, statistics and other information with respect to: The cost of its operations; the patterns of service utilization; the availability, accessibility, and acceptability of its services; to the extent practical, developments in the health status of its enrollees; information demonstrating that the MAO has a fiscally sound operation; and other matters that CMS may require. CMS also has oversight authority over cost plans which includes establishment of reporting requirements. The changes for the 2019 reporting requirements under Organization Determinations and Reconsiderations (ODR) will add 18 new data elements to the reporting section. The new data elements will allow CMS to obtain more information about who is submitting requests for ODR and whether the service or claim is being provided by a contract or non-contract provider. The timeliness requirement for ODR will also be eliminated to be consistent with Part D reporting. In addition, the number of data reporting elements of grievances is reduced from 23 to 19. The reporting sections for Private Fee For Service (PFFS) Payment Dispute Resolution Process and Mid-Year Network Changes will also be suspended. Form Number: CMS-10261 (OMB control number: 0938-1054); Frequency: Yearly and semi-annually; Affected Public: Private sector (business or other for-profits); Number of Respondents: 432; Total Annual Responses: 3,024; Total Annual Hours: 127,329. (For policy questions regarding this collection contact Maria Sotirelis at 410-786-0552.) Dated: March 21, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-06052 Filed 3-23-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Notices 12951
supplies (other than commercially Responses per Respondent: 3. extension or reinstatement of an existing
available off-the-shelf (COTS) items) to Annual Responses: 17,727. collection of information) and to allow
be acquired outside the United States, or Hours per Response: 12. 60 days for public comment on the
the services to be performed, outside the Total Burden Hours: 212,724. proposed action. Interested persons are
United States has an estimated value C. Public Comments invited to send comments regarding our
that exceeds $500,000. These burden estimates or any other aspect of
protections include the following: (a) Public comments are particularly this collection of information, including
The contractor is required to implement invited on: Whether this collection of the necessity and utility of the proposed
and maintain a compliance plan during information is necessary for the proper information collection for the proper
the performance of the contract that performance of functions of the FAR, performance of the agency’s functions,
includes an awareness program, a and whether it will have practical the accuracy of the estimated burden,
process for employees to report activity utility; whether our estimate of the ways to enhance the quality, utility, and
inconsistent with the zero-tolerance public burden of this collection of clarity of the information to be
policy, a recruitment and wage plan, a information is accurate, and based on collected, and the use of automated
housing plan, and procedures to prevent valid assumptions and methodology; collection techniques or other forms of
subcontractors from engaging in ways to enhance the quality, utility, and information technology to minimize the
trafficking in persons; and (b) The clarity of the information to be information collection burden.
contractor is required to submit a collected; and ways in which we can
minimize the burden of the collection of DATES: Comments must be received by
certification to the contracting officer May 25, 2018.
prior to receiving an award, and information on those who are to
respond, through the use of appropriate ADDRESSES: When commenting, please
annually thereafter, asserting that it has
the required compliance plan in place technological collection techniques or reference the document identifier or
and that there have been no abuses, or other forms of information technology. OMB control number. To be assured
that appropriate actions have been taken Obtaining Copies of Proposals: consideration, comments and
if abuses have been found. The Requesters may obtain a copy of the recommendations must be submitted in
compliance plan must be provided to information collection documents from any one of the following ways:
the contracting officer upon request, and the General Services Administration, 1. Electronically. You may send your
relevant portions of it must be posted at Regulatory Secretariat Division (MVCB), comments electronically to http://
the workplace and on the contractor’s 1800 F Street NW, Washington, DC www.regulations.gov. Follow the
website. Additionally, contractors are 20405, telephone 202–501–4755. instructions for ‘‘Comment or
required to flow these requirements Please cite OMB Control No. 9000– Submission’’ or ‘‘More Search Options’’
down to any subcontracts where the 0188, Combating Trafficking in Persons, to find the information collection
estimated value of the supplies acquired in all correspondence. document(s) that are accepting
or the services required to be performed Dated: March 20, 2018. comments.
outside the United States exceeds Lorin S. Curit, 2. By regular mail. You may mail
$500,000. Director, Federal Acquisition Policy Division, written comments to the following
Office of Governmentwide Acquisition Policy, address: CMS, Office of Strategic
B. Annual Reporting Burden Office of Acquisition Policy, Office of Operations and Regulatory Affairs,
Title, Associated Form, and OMB Governmentwide Policy. Division of Regulations Development,
Number: Ending Trafficking in Persons, [FR Doc. 2018–06043 Filed 3–23–18; 8:45 am] Attention: Document Identifier/OMB
FAR 22.1705 and FAR 52.222–50 and BILLING CODE 6820–EP–P Control Number ___, Room C4–26–05,
52.222–56; OMB Control Number 9000– 7500 Security Boulevard, Baltimore,
0188. Maryland 21244–1850.
Adjustment: This information DEPARTMENT OF HEALTH AND To obtain copies of a supporting
collection is revised to include HUMAN SERVICES statement and any related forms for the
appropriate burden hours for reporting proposed collection(s) summarized in
that was initially published in FAR Case Centers for Medicare & Medicaid this notice, you may make your request
2013–001 (78 FR 59317 and 80 FR 4967) Services using one of following:
for FAR clause 52.222–50, Combating 1. Access CMS’ website address at
[Document Identifiers: CMS–10249 and
Trafficking in Persons, and provision https://www.cms.gov/Regulations-and-
CMS–10261]
52.222–56, Certification Regarding Guidance/Legislation/Paperwork
Trafficing in Persons Compliance Plan. Agency Information Collection ReductionActof1995/PRA-Listing.html.
The full burden associated with this Activities: Proposed Collection; 2. Email your request, including your
FAR Case was inadvertently omitted in Comment Request address, phone number, OMB number,
the Paperwork Reduction Act notice and CMS document identifier, to
published on August 20, 2014 (78 FR AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov.
59317). The following represents Medicaid Services, HHS. 3. Call the Reports Clearance Office at
current burdens associated with the ACTION: Notice. (410) 786–1326.
FAR clause and provision that were FOR FURTHER INFORMATION CONTACT:
published in the proposed and final SUMMARY: The Centers for Medicare &
Medicaid Services (CMS) is announcing William Parham at (410) 786–4669.
rules.
an opportunity for the public to
sradovich on DSK3GMQ082PROD with NOTICES
Affected Public: Businesses and other SUPPLEMENTARY INFORMATION:
for-profit entities. comment on CMS’ intention to collect
information from the public. Under the Contents
Respondent’s Obligation: Required to
obtain or retain benefits. Paperwork Reduction Act of 1995 (the This notice sets out a summary of the
Type of Request: Revision of a PRA), federal agencies are required to use and burden associated with the
currently approved collection. publish notice in the Federal Register following information collections. More
Reporting Frequency: On occasion. concerning each proposed collection of detailed information can be found in
Respondents: 5,909. information (including each proposed each collection’s supporting statement
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![12952 Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Notices
and associated materials (see progress report is used by the national regarding this collection contact Maria
ADDRESSES). evaluation contractor and CMS to Sotirelis at 410–786–0552.)
CMS–10249 Administrative monitor program implementation at the Dated: March 21, 2018.
Requirements for Section 6071 of grantee level. Form Number: CMS– William N. Parham, III,
the Deficit Reduction Act 10249 (OMB control number: 0938– Director, Paperwork Reduction Staff, Office
CMS–10261 Part C Medicare Advantage 1053); Frequency: Yearly, quarterly, and of Strategic Operations and Regulatory
Reporting Requirements and semi-annually; Affected Public: State, Affairs.
Supporting Regulations in 42 CFR Local, or Tribal Governments; Number [FR Doc. 2018–06052 Filed 3–23–18; 8:45 am]
422.516(a) of Respondents: 45; Total Annual BILLING CODE 4120–01–P
Under the PRA (44 U.S.C. 3501– Responses: 28,590; Total Annual Hours:
3520), federal agencies must obtain 14,225. (For policy questions regarding
approval from the Office of Management this collection contact Effie George at DEPARTMENT OF HEALTH AND
and Budget (OMB) for each collection of 410–786–8639.) HUMAN SERVICES
information they conduct or sponsor. 2. Type of Information Collection
The term ‘‘collection of information’’ is Request: Revision of a currently Food and Drug Administration
defined in 44 U.S.C. 3502(3) and 5 CFR approved collection; Title of [Docket No. FDA–2018–D–1067]
1320.3(c) and includes agency requests Information Collection: Part C Medicare
or requirements that members of the Advantage Reporting Requirements and Evaluation of Bulk Drug Substances
public submit reports, keep records, or Supporting Regulations in 42 CFR Nominated for Use in Compounding
provide information to a third party. 422.516(a); Use: Medicare Advantage Under Section 503B of the Federal
Section 3506(c)(2)(A) of the PRA Organizations (MAOs) must have an Food, Drug, and Cosmetic Act; Draft
requires federal agencies to publish a effective procedure to develop, compile, Guidance for Industry; Availability
60-day notice in the Federal Register evaluate, and report to CMS, to its
concerning each proposed collection of AGENCY: Food and Drug Administration,
enrollees, and to the general public, at HHS.
information, including each proposed the times and in the manner that CMS
extension or reinstatement of an existing ACTION: Notice of availability.
requires, and while safeguarding the
collection of information, before confidentiality of the doctor-patient SUMMARY: The Food and Drug
submitting the collection to OMB for relationship, statistics and other Administration (FDA or the Agency) is
approval. To comply with this information with respect to: The cost of announcing the availability of a draft
requirement, CMS is publishing this its operations; the patterns of service guidance for industry entitled
notice.
utilization; the availability, ‘‘Evaluation of Bulk Drug Substances
Information Collection accessibility, and acceptability of its Nominated for Use in Compounding
1. Type of Information Collection services; to the extent practical, Under Section 503B of the Federal
Request: Extension of a currently developments in the health status of its Food, Drug, and Cosmetic Act.’’ This
approved collection; Title of enrollees; information demonstrating draft guidance describes policies that
Information Collection: Administrative that the MAO has a fiscally sound FDA proposes to use in evaluating bulk
Requirements for Section 6071 of the operation; and other matters that CMS drug substances nominated for use in
Deficit Reduction Act; Use: State may require. CMS also has oversight compounding under section 503B of the
Operational Protocols should provide authority over cost plans which Federal Food, Drug, and Cosmetic Act
enough information such that: The CMS includes establishment of reporting (FD&C Act) for inclusion on the list of
Project Officer and other federal officials requirements. The changes for the 2019 bulk drug substances that can be used
may use it to understand the operation reporting requirements under in compounding under section 503B.
of the demonstration, prepare for Organization Determinations and DATES: Submit either electronic or
potential site visits without needing Reconsiderations (ODR) will add 18 written comments on the draft guidance
additional information, or both; the new data elements to the reporting by May 25, 2018 to ensure that the
State Project Director can use it as the section. The new data elements will Agency considers your comment on this
manual for program implementation; allow CMS to obtain more information draft guidance before it begins work on
and external stakeholders may use it to about who is submitting requests for the final version of the guidance.
understand the operation of the ODR and whether the service or claim ADDRESSES: You may submit comments
demonstration. The financial is being provided by a contract or non- on any guidance at any time as follows:
information collection is used in our contract provider. The timeliness
financial statements and shared with the requirement for ODR will also be Electronic Submissions
auditors who validate CMS’ financial eliminated to be consistent with Part D Submit electronic comments in the
position. The Money Follows the Person reporting. In addition, the number of following way:
Rebalancing Demonstration (MFP) data reporting elements of grievances is • Federal eRulemaking Portal:
Finders File, MFP Program Participation reduced from 23 to 19. The reporting https://www.regulations.gov. Follow the
Data file, and MFP Services File are sections for Private Fee For Service instructions for submitting comments.
used by the national evaluation (PFFS) Payment Dispute Resolution Comments submitted electronically,
contractor to assess program outcomes Process and Mid-Year Network Changes including attachments, to https://
while we use the information to monitor will also be suspended. Form Number: www.regulations.gov will be posted to
sradovich on DSK3GMQ082PROD with NOTICES
program implementation. The MFP CMS–10261 (OMB control number: the docket unchanged. Because your
Quality of Life data is used by the 0938–1054); Frequency: Yearly and comment will be made public, you are
national evaluation contractor to assess semi-annually; Affected Public: Private solely responsible for ensuring that your
program outcomes. The evaluation is sector (business or other for-profits); comment does not include any
used to determine how participants’ Number of Respondents: 432; Total confidential information that you or a
quality of life changes after transitioning Annual Responses: 3,024; Total Annual third party may not wish to be posted,
to the community. The semi-annual Hours: 127,329. (For policy questions such as medical information, your or
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Document Created: 2018-03-24 00:59:53
Document Modified: 2018-03-24 00:59:53
| 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 May 25, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 12951 |
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