81_FR_33639 81 FR 33537 - Agency Information Collection Activities: Proposed Collection; Comment Request

81 FR 33537 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 102 (May 26, 2016)

Page Range33537-33538
FR Document2016-12476

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 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.

Federal Register, Volume 81 Issue 102 (Thursday, May 26, 2016) 
[Federal Register Volume 81, Number 102 (Thursday, May 26, 2016)]
[Notices]
[Pages 33537-33538]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10053 and CMS-10302]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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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 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 must be received by July 25, 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 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 Paperwork@cms.hhs.gov.
    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-10053 Paid Feeding Assistants in Long-Term Care Facilities and 
Supporting Regulations

CMS-10302 Collection Requirements for Compendia for Determination of 
Medically-accepted Indications for Off-label Uses of Drugs and 
Biologicals in an Anti-cancer Chemotherapeutic Regimen

    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: Extension of a currently 
approved collection; Title of Information Collection: Paid Feeding 
Assistants in Long-Term Care Facilities and Supporting Regulations; 
Use: In accordance with 42 CFR part 483, long-term care facilities are 
permitted to use paid feeding assistants to supplement the services of 
certified nurse aides. If facilities choose this option, feeding 
assistants must complete a training program. Nursing home providers are 
expected to maintain a record of all individuals used by the facility 
as paid feeding assistants. Form Number: CMS-10053 (OMB control number: 
0938-0916); Frequency: Occasionally; Affected Public: Private Sector--
Business or other for-profit and not-for-profit institutions; Number of 
Respondents: 4,250; Total Annual Responses: 4,250; Total Annual Hours: 
25,500. (For policy questions regarding this collection contact Karen 
Tritz at 410-786-8021.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Collection 
Requirements for Compendia for Determination of Medically-accepted 
Indications for Off-label Uses of Drugs and Biologicals in an Anti-
cancer Chemotherapeutic Regimen Use: Section 182(b) of the Medicare 
Improvement of Patients and Providers Act (MIPPA) amended section 
1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by 
adding at the end the following new sentence: `On and after January 1, 
2010, no compendia may be included on the list of compendia under this 
subparagraph unless the compendia has a publicly transparent process 
for evaluating therapies and for identifying potential conflicts of 
interest.' We believe that the implementation of this statutory 
provision that compendia have a ``publicly transparent process for 
evaluating therapies and for identifying potential conflicts of 
interests'' is best accomplished by amending 42 CFR 414.930 to include 
the MIPPA requirements and by defining the key components of publicly 
transparent processes for evaluating therapies and

[[Page 33538]]

for identifying potential conflicts of interests.
    All currently listed compendia will be required to comply with 
these provisions, as of January 1, 2010, to remain on the list of 
recognized compendia. In addition, any compendium that is the subject 
of a future request for inclusion on the list of recognized compendia 
will be required to comply with these provisions. No compendium can be 
on the list if it does not fully meet the standard described in section 
1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA. 
Form Number: CMS-10302 (OMB control number: 0938-1078); Frequency: 
Annually; Affected Public: Business and other for-profits and Not-for-
profit institutions; Number of Respondents: 845; Total Annual 
Responses: 900; Total Annual Hours: 5,135. (For policy questions 
regarding this collection contact Brijet Coachman at 410-786-7364.)

    Dated: May 23, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-12476 Filed 5-25-16; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 81, No. 102 / Thursday, May 26, 2016 / Notices 33537 B, I) (OMB control number: 0938–0685); consideration, comments and Section 3506(c)(2)(A) of the PRA Frequency: Annually; Affected Public: recommendations must be submitted in requires federal agencies to publish a Private Sector; Business or other for- any one of the following ways: 60-day notice in the Federal Register profit and not-for-profit institutions; 1. Electronically. You may send your concerning each proposed collection of Number of Respondents: 1,735,800; comments electronically to http:// information, including each proposed Total Annual Responses: 86,480; Total www.regulations.gov. Follow the extension or reinstatement of an existing Annual Hours: 290,193. (For policy instructions for ‘‘Comment or collection of information, before questions regarding this collection Submission’’ or ‘‘More Search Options’’ submitting the collection to OMB for contact Kimberly McPhillips at 410– to find the information collection approval. To comply with this 786–5374.) document(s) that are accepting requirement, CMS is publishing this Dated: May 20, 2016. comments. notice. 2. By regular mail. You may mail 1. Type of Information Collection William N. Parham, III, written comments to the following Request: Extension of a currently Director, Paperwork Reduction Staff, Office address: CMS, Office of Strategic approved collection; Title of of Strategic Operations and Regulatory Information Collection: Paid Feeding Affairs. Operations and Regulatory Affairs, Division of Regulations Development, Assistants in Long-Term Care Facilities [FR Doc. 2016–12376 Filed 5–25–16; 8:45 am] Attention: Document Identifier/OMB and Supporting Regulations; Use: In BILLING CODE 4120–01–P Control Number llll, Room C4–26– accordance with 42 CFR part 483, long- 05, 7500 Security Boulevard, Baltimore, term care facilities are permitted to use Maryland 21244–1850. paid feeding assistants to supplement DEPARTMENT OF HEALTH AND the services of certified nurse aides. If To obtain copies of a supporting HUMAN SERVICES facilities choose this option, feeding statement and any related forms for the Centers for Medicare & Medicaid proposed collection(s) summarized in assistants must complete a training Services this notice, you may make your request program. Nursing home providers are using one of following: expected to maintain a record of all [Document Identifiers: CMS–10053 and 1. Access CMS’ Web site address at individuals used by the facility as paid CMS–10302] http://www.cms.hhs.gov/ feeding assistants. Form Number: CMS– PaperworkReductionActof1995. 10053 (OMB control number: 0938– Agency Information Collection 2. Email your request, including your 0916); Frequency: Occasionally; Activities: Proposed Collection; address, phone number, OMB number, Affected Public: Private Sector— Comment Request and CMS document identifier, to Business or other for-profit and not-for- AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov. profit institutions; Number of Medicaid Services, HHS. 3. Call the Reports Clearance Office at Respondents: 4,250; Total Annual (410) 786–1326. Responses: 4,250; Total Annual Hours: ACTION: Notice. FOR FURTHER INFORMATION CONTACT: 25,500. (For policy questions regarding SUMMARY: The Centers for Medicare & Reports Clearance Office at (410) 786– this collection contact Karen Tritz at Medicaid Services (CMS) is announcing 1326. 410–786–8021.) an opportunity for the public to 2. Type of Information Collection SUPPLEMENTARY INFORMATION: Request: Extension of a currently comment on CMS’ intention to collect information from the public. Under the Contents approved collection; Title of Paperwork Reduction Act of 1995 (the Information Collection: Collection This notice sets out a summary of the PRA), federal agencies are required to Requirements for Compendia for use and burden associated with the publish notice in the Federal Register Determination of Medically-accepted following information collections. More concerning each proposed collection of Indications for Off-label Uses of Drugs detailed information can be found in information (including each proposed and Biologicals in an Anti-cancer each collection’s supporting statement Chemotherapeutic Regimen Use: extension or reinstatement of an existing and associated materials (see collection of information) and to allow Section 182(b) of the Medicare ADDRESSES). 60 days for public comment on the Improvement of Patients and Providers proposed action. Interested persons are CMS–10053 Paid Feeding Assistants Act (MIPPA) amended section invited to send comments regarding our in Long-Term Care Facilities and 1861(t)(2)(B) of the Social Security Act burden estimates or any other aspect of Supporting Regulations (42 U.S.C. 1395x(t)(2)(B)) by adding at this collection of information, including the end the following new sentence: ‘On CMS–10302 Collection Requirements and after January 1, 2010, no compendia any of the following subjects: The for Compendia for Determination of may be included on the list of necessity and utility of the proposed Medically-accepted Indications for Off- compendia under this subparagraph information collection for the proper label Uses of Drugs and Biologicals in unless the compendia has a publicly performance of the agency’s functions; an Anti-cancer Chemotherapeutic transparent process for evaluating the accuracy of the estimated burden; Regimen therapies and for identifying potential ways to enhance the quality, utility, and Under the PRA (44 U.S.C. 3501– conflicts of interest.’ We believe that the clarity of the information to be 3520), federal agencies must obtain implementation of this statutory collected; and the use of automated approval from the Office of Management provision that compendia have a collection techniques or other forms of and Budget (OMB) for each collection of ‘‘publicly transparent process for sradovich on DSK3TPTVN1PROD with NOTICES information technology to minimize the information they conduct or sponsor. evaluating therapies and for identifying information collection burden. The term ‘‘collection of information’’ is potential conflicts of interests’’ is best DATES: Comments must be received by defined in 44 U.S.C. 3502(3) and 5 CFR accomplished by amending 42 CFR July 25, 2016. 1320.3(c) and includes agency requests 414.930 to include the MIPPA ADDRESSES: When commenting, please or requirements that members of the requirements and by defining the key reference the document identifier or public submit reports, keep records, or components of publicly transparent OMB control number. To be assured provide information to a third party. processes for evaluating therapies and VerDate Sep<11>2014 18:47 May 25, 2016 Jkt 238001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\26MYN1.SGM 26MYN1

33538 Federal Register / Vol. 81, No. 102 / Thursday, May 26, 2016 / Notices for identifying potential conflicts of DATES: The two-year project period for and direct services to survivors of interests. the award is December 1, 2015 through torture. All currently listed compendia will be November 30, 2017. Gulf Coast’s National Partnership for required to comply with these FOR FURTHER INFORMATION CONTACT: Community Training (NPCT) has provisions, as of January 1, 2010, to Kenneth Tota, Deputy Director, Office of provided technical assistance and remain on the list of recognized Refugee Resettlement, 330 C. Street, training services to ORR grantees and compendia. In addition, any SW., Washington, DC 20201. Telephone: other refugee service providers since compendium that is the subject of a 202–401–4858. Email: kenneth.tota@ 2006. It is expected that ORR will provide future request for inclusion on the list acf.hhs.gov awards to this grantee for a 2-year of recognized compendia will be SUPPLEMENTARY INFORMATION: In the past project period with 12-month budget required to comply with these few years, ORR has seen an increasing periods. The grantee will be required to provisions. No compendium can be on need for mental health services among submit applications for noncompetitive the list if it does not fully meet the newly-arrived refugees, particularly awards in the subsequent year during standard described in section those who have suffered torture and the project period. Future awards will 1861(t)(2)(B) of the Act, as revised by extreme trauma due to war and be based on the grantee’s performance, section 182(b) of the MIPPA. Form genocide. ORR has received numerous the availability of funds, and the best Number: CMS–10302 (OMB control reports of refugees from Bhutan and interest of the Federal Government. number: 0938–1078); Frequency: Annually; Affected Public: Business and Burma completing suicide. Bhutanese Statutory Authority: This program is other for-profits and Not-for-profit refugees, in particular, have authorized by— institutions; Number of Respondents: demonstrated a high incidence of (A) Section 412 (c)(1)(A) of the suicide upon arrival to the U.S. This Immigration and Nationality Act (INA)(8 845; Total Annual Responses: 900; Total U.S.C. 1522(c)(1)(A)), as amended, which Annual Hours: 5,135. (For policy fiscal year the program is seeing a significant increase in resettlement of authorizes the Director ‘‘to make grants to, questions regarding this collection and enter into contracts with, public or contact Brijet Coachman at 410–786– refugees from the Democratic Republic private nonprofit agencies for projects 7364.) of Congo and Syria. specifically designed—[. . .](i) to assist Refugees face significant barriers to refugees in obtaining the skills that are Dated: May 23, 2016. accessing mental health resources since necessary for economic self-sufficiency, William N. Parham, III, they are unfamiliar with community including projects for job training, Director, Paperwork Reduction Staff, Office mental health systems, speak limited employment services, day care, professional of Strategic Operations and Regulatory refresher training, and other recertification English, and have few financial Affairs. services; (ii) to provide training in English resources. Health and mental health where necessary (regardless of whether the [FR Doc. 2016–12476 Filed 5–25–16; 8:45 am] providers are often overwhelmed by the refugees are employed or receiving cash or BILLING CODE 4120–01–P linguistic and cultural differences that other assistance); and (iii) to provide where refugees present and respond by saying specific needs have been shown and they are unable to provide services. recognized by the Director, health (including DEPARTMENT OF HEALTH AND Currently the provision of standardized mental health) services, social services, HUMAN SERVICES mental health screening and culturally education and other services.’’ (B) Refugee Assistance Extension Act of appropriate mental health services is Administration for Children and 1986, Pub.L. 99–605, Nov 6, 1986, 100 Stat. one the primary challenges facing the 3449. Families US resettlement program. There is no direct provision of much needed mental Christopher Beach, [CFDA Number: 93.576] health services to refugees in many Senior Grants Policy Specialist, Division of primary resettlement locations. Grants Policy, Office of Administration. Announcement of Award of an Urgent [FR Doc. 2016–12462 Filed 5–25–16; 8:45 am] Gulf Coast has been a longstanding Single-Source Grant to Gulf Coast refugee resettlement program and also BILLING CODE 4184–45–P Jewish Family and Community has been a grantee under the ORR Services in Clearwater, FL Survivors of Torture program for the past 15 years. In addition, Gulf Coast DEPARTMENT OF HEALTH AND AGENCY:Office of Refugee Resettlement, HUMAN SERVICES ACF, HHS. has provided technical assistance and mental health services to a national ACTION: Notice of the award of an urgent Food and Drug Administration network of refugee service providers single-source grant to Gulf Coast Jewish and mainstream health and mental [Docket No. FDA–2009–D–0430] Family and Community Services to health professionals for the past 9 years. provide mental health technical Gulf Coast is recognized as the primary Ingredients Declared as Evaporated assistance services for refugees. refugee mental health technical Cane Juice; Guidance for Industry; assistance provider to states without a Availability SUMMARY: The Administration for survivor of torture program. As a result AGENCY: Food and Drug Administration, Children and Families (ACF), Office of of Gulf Coast’s training and technical HHS. Refugee Resettlement (ORR) announces assistance 6 states applied for and ACTION: Notice of availability. the award of an urgent single-source received ORR grants to provide direct sradovich on DSK3TPTVN1PROD with NOTICES grant in the amount of $225,000 to Gulf services to survivors. They are the only SUMMARY: The Food and Drug Coast Jewish Family and Community technical assistance provider with Administration (FDA or we) is Services (Gulf Coast) in Clearwater, FL expertise in both refugee resettlement announcing the availability of a to train providers to effectively identify and direct services to survivors of guidance entitled ‘‘Ingredients Declared and appropriately serve the mental torture. They are the only national as Evaporated Cane Juice.’’ The health needs of arriving refugee technical assistance provider with document advises industry of FDA’s populations. expertise in both refugee resettlement view that sweeteners derived from sugar VerDate Sep<11>2014 18:47 May 25, 2016 Jkt 238001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\26MYN1.SGM 26MYN1


Document Created: 2016-05-26 01:13:20
Document Modified: 2016-05-26 01:13:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments must be received by July 25, 2016.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation81 FR 33537 
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