81 FR 11571 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 43 (March 4, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 43 (March 4, 2016)
| Page Range | 11571-11572 | |
| FR Document | 2016-04861 |
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)] [Notices] [Pages 11571-11572] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04861] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10152] 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 May 3, 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 [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-10152 Data Collection for Medicare Beneficiaries Receiving NaF-18 Positron Emission Tomography (PET) To Identify Bone Metastasis in Cancer 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 previously approved collection; Title: Data Collection for Medicare Beneficiaries Receiving NaF-18 Positron Emission Tomography (PET) to Identify Bone Metastasis in Cancer; Use: In Decision Memorandum #CAG- 00065R, issued on February 26, 2010, the Centers for Medicare and Medicaid Services (CMS) determined that the evidence is sufficient to conclude that for Medicare beneficiaries receiving NaF-18 PET scan to identify bone metastasis in cancer is reasonable and necessary only when the provider is participating in and patients are enrolled in a clinical study designed to information at the time of the scan to assist in initial antitumor treatment planning or to guide subsequent treatment strategy by the identification, location and quantification of bone metastases in beneficiaries in whom bone metastases are strongly suspected based on clinical symptoms or the results of other diagnostic studies. Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected; hospitals and providers are qualified to provide the PET scan and interpret the results; participating hospitals and [[Page 11572]] providers accurately report data on all Medicare enrolled patients; and all patient confidentiality, privacy, and other Federal laws must be followed. Consistent with section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meets specified standards and address the specified research questions. To qualify for payment, providers must prescribe certain NaF-18 PET scans for beneficiaries with a set of clinical criteria specific to each solid tumor. The statuary authority for this policy is section 1862(a)(1)(E) of the Act. The need to prospectively collect information at the time of the scan is to assist the provider in decision making for patient management. Form Number: CMS-10152 (OCN: 0938-0968); Frequency: Annual; Affected Public: Private Sector (Business or other for-profits); Number of Respondents: 25,000; Total Annual Responses: 25,000; Total Annual Hours: 2,084 hours. (For policy questions regarding this collection contact Stuart Caplan at 410-786-8564.) Dated: March 1, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-04861 Filed 3-3-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices 11571
certified as QHPs by the Exchange. A PRA), federal agencies are require; to Contents
QHP must meet certain minimum publish notice in the Federal Register This notice sets out a summary of the
certification standards, such as network concerning each proposed collection of use and burden associated with the
adequacy, inclusion of Essential information (including each proposed following information collections. More
Community Providers (ECPs), and non- extension or reinstatement of an existing detailed information can be found in
discrimination. The Exchange is collection of information) and to allow each collection’s supporting statement
responsible for ensuring that QHPs meet 60 days for public comment on the and associated materials (see
these minimum certification standards proposed action. Interested persons are ADDRESSES).
as described in the Exchange rule under invited to send comments regarding our
45 CFR parts 155 and 156, based on the burden estimates or any other aspect of CMS–10152 Data Collection for
Affordable Care Act, as well as other this collection of information, including Medicare Beneficiaries Receiving NaF–
standards determined by the Exchange. any of the following subjects: (1) The 18 Positron Emission Tomography
The reporting requirements and data necessity and utility of the proposed (PET) To Identify Bone Metastasis in
collection in the Exchange rule address information collection for the proper Cancer
Federal requirements that various performance of the agency’s functions; Under the PRA (44 U.S.C. 3501–
entities must meet with respect to the (2) the accuracy of the estimated 3520), federal agencies must obtain
establishment and operation of an burden; (3) ways to enhance the quality, approval from the Office of Management
Exchange; minimum requirements that utility, and clarity of the information to and Budget (OMB) for each collection of
health insurance issuers must meet with be collected; and (4) the use of information they conduct or sponsor.
respect to participation in a State based automated collection techniques or The term ‘‘collection of information’’ is
or Federally-facilitated Exchange; and other forms of information technology to defined in 44 U.S.C. 3502(3) and 5 CFR
requirements that employers must meet minimize the information collection 1320.3(c) and includes agency requests
with respect to participation in the burden. or requirements that members of the
SHOP and compliance with other
DATES: Comments must be received by public submit reports, keep records, or
provisions of the Affordable Care Act.
May 3, 2016. provide information to a third party.
Comments have been received,
Section 3506(c)(2)(A) of the PRA
however; there were no comments that ADDRESSES: When commenting, please
requires federal agencies to publish a
impacted the burden, and therefore no reference the document identifier or 60-day notice in the Federal Register
additional changes were made. Form OMB control number. To be assured concerning each proposed collection of
Number: CMS–10593 (OMB Control consideration, comments and information, including each proposed
Number: 0938–NEW); Frequency: recommendations must be submitted in extension or reinstatement of an existing
Annually, Monthly; Affected Public: any one of the following ways: collection of information, before
Private Sector; Business or other for- 1. Electronically. You may send your submitting the collection to OMB for
profit; Number of Respondents: 20; comments electronically to http:// approval. To comply with this
Total Annual Responses: 400; Total www.regulations.gov. Follow the requirement, CMS is publishing this
Annual Hours: 36,900. (For policy instructions for ‘‘Comment or notice.
questions regarding this collection Submission’’ or ‘‘More Search Options’’ 1. Type of Information Collection
contact Christy Woods at 301–492– to find the information collection Request: Extension of a previously
5140.) document(s) that are accepting approved collection; Title: Data
Dated: March 1, 2016. comments. Collection for Medicare Beneficiaries
William N. Parham, III, 2. By regular mail. You may mail Receiving NaF–18 Positron Emission
Director, Paperwork Reduction Staff, Office written comments to the following Tomography (PET) to Identify Bone
of Strategic Operations and Regulatory address: CMS, Office of Strategic Metastasis in Cancer; Use: In Decision
Affairs. Operations and Regulatory Affairs, Memorandum #CAG–00065R, issued on
[FR Doc. 2016–04841 Filed 3–3–16; 8:45 am] Division of Regulations Development, February 26, 2010, the Centers for
BILLING CODE 4120–01–P Attention: Document Identifier/OMB Medicare and Medicaid Services (CMS)
Control Number _________, Room C4– determined that the evidence is
26–05, 7500 Security Boulevard, sufficient to conclude that for Medicare
DEPARTMENT OF HEALTH AND Baltimore, Maryland 21244–1850. beneficiaries receiving NaF–18 PET scan
HUMAN SERVICES To obtain copies of a supporting to identify bone metastasis in cancer is
statement and any related forms for the reasonable and necessary only when the
Centers for Medicare & Medicaid proposed collection(s) summarized in provider is participating in and patients
Services this notice, you may make your request are enrolled in a clinical study designed
[Document Identifier: CMS–10152] using one of following: to information at the time of the scan to
1. Access CMS’ Web site address at assist in initial antitumor treatment
Agency Information Collection http://www.cms.hhs.gov/ planning or to guide subsequent
Activities: Proposed Collection; PaperworkReductionActof1995. treatment strategy by the identification,
Comment Request 2. Email your request, including your location and quantification of bone
AGENCY: Centers for Medicare & address, phone number, OMB number, metastases in beneficiaries in whom
Medicaid Services, HHS. and CMS document identifier, to bone metastases are strongly suspected
based on clinical symptoms or the
jstallworth on DSK7TPTVN1PROD with NOTICES
ACTION: Notice. Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at results of other diagnostic studies.
SUMMARY: The Centers for Medicare & (410) 786–1326. Qualifying clinical studies must ensure
Medicaid Services (CMS) is announcing that specific hypotheses are addressed;
FOR FURTHER INFORMATION CONTACT:
an opportunity for the public to appropriate data elements are collected;
Reports Clearance Office at (410) 786–
comment on CMS’ intention to collect hospitals and providers are qualified to
1326.
information from the public. Under the provide the PET scan and interpret the
Paperwork Reduction Act of 1995 (the SUPPLEMENTARY INFORMATION: results; participating hospitals and
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![11572 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices
providers accurately report data on all illness associated with consumption of Management, FDA will post your
Medicare enrolled patients; and all produce grown in fields or other comment, as well as any attachments,
patient confidentiality, privacy, and growing areas amended with untreated except for information submitted,
other Federal laws must be followed. biological soil amendments of animal marked and identified, as confidential,
Consistent with section 1142 of the origin that are potentially contaminated if submitted as detailed in
Social Security Act (the Act), the with enteric pathogens, such as ‘‘Instructions.’’
Agency for Healthcare Research and Escherichia coli O157:H7 or Salmonella. Instructions: All submissions received
Quality (AHRQ) supports clinical The risk assessment also will evaluate must include the Docket No. FDA–
research studies that CMS determines the impact of certain interventions, such 2016–N–0321 for ‘‘Risk Assessment of
meets specified standards and address as use of a time interval between Foodborne Illness Associated with
the specified research questions. To application of the soil amendment and Pathogens from Produce Grown in
qualify for payment, providers must crop harvest, on the predicted risk. The Fields Amended with Untreated
prescribe certain NaF–18 PET scans for risk assessment is intended to inform Biological Soil Amendments of Animal
beneficiaries with a set of clinical policy decisions with regard to produce Origin; Request for Comments,
criteria specific to each solid tumor. The safety. Scientific Data, and Information’’.
statuary authority for this policy is DATES: Submit either electronic or
Received comments and scientific data
section 1862(a)(1)(E) of the Act. The written comments and scientific data and information will be placed in the
need to prospectively collect and information by May 3, 2016. docket and, except for those submitted
information at the time of the scan is to as ‘‘Confidential Submissions,’’ publicly
ADDRESSES: You may submit comments viewable at http://www.regulations.gov
assist the provider in decision making
for patient management. Form Number: and scientific data and information as or at the Division of Dockets
CMS–10152 (OCN: 0938–0968); follows: Management between 9 a.m. and 4 p.m.,
Frequency: Annual; Affected Public: Electronic Submissions Monday through Friday.
Private Sector (Business or other for- • Confidential Submissions—To
Submit electronic comments and submit a comment with confidential
profits); Number of Respondents:
25,000; Total Annual Responses: scientific data and information in the information that you do not wish to be
25,000; Total Annual Hours: 2,084 following way: made publicly available submit your
hours. (For policy questions regarding • Federal eRulemaking Portal: http:// comments and scientific data and
this collection contact Stuart Caplan at www.regulations.gov. Follow the information only as a written/paper
410–786–8564.) instructions for submitting comments. submission. You should submit two
Comments and scientific data and copies total. One copy will include the
Dated: March 1, 2016. information submitted electronically, information you claim to be confidential
William N. Parham, III, including attachments, to http:// with a heading or cover note that states
Director, Paperwork Reduction Staff, Office www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS
of Strategic Operations and Regulatory the docket unchanged. Because your
Affairs.
CONFIDENTIAL INFORMATION’’. The
comment will be made public, you are Agency will review this copy, including
[FR Doc. 2016–04861 Filed 3–3–16; 8:45 am] solely responsible for ensuring that your the claimed confidential information, in
BILLING CODE 4120–01–P comment does not include any its consideration of comments and
confidential information that you or a scientific data and information. The
third party may not wish to be posted, second copy, which will have the
DEPARTMENT OF HEALTH AND such as medical information, your or claimed confidential information
HUMAN SERVICES anyone else’s Social Security number, or redacted/blacked out, will be available
Food and Drug Administration confidential business information, such for public viewing and posted on http://
as a manufacturing process. Please note www.regulations.gov. Submit both
[Docket No. FDA–2016–N–0321] that if you include your name, contact copies to the Division of Dockets
information, or other information that Management. If you do not wish your
Risk Assessment of Foodborne Illness identifies you in the body of your name and contact information to be
Associated With Pathogens From comments and scientific data and made publicly available, you can
Produce Grown in Fields Amended information, that information will be provide this information on the cover
With Untreated Biological Soil posted on http://www.regulations.gov. sheet and not in the body of your
Amendments of Animal Origin; • If you want to submit a comment comments and scientific data and
Request for Scientific Data, with confidential information that you information and you must identify this
Information, and Comments do not wish to be made available to the information as ‘‘confidential.’’ Any
AGENCY: Food and Drug Administration, public, submit the comment as a information marked as ‘‘confidential’’
HHS. written/paper submission and in the will not be disclosed except in
ACTION: Notice; request for comments manner detailed (see ‘‘Written/Paper accordance with 21 CFR 10.20 and other
and for scientific data and information. Submissions’’ and ‘‘Instructions’’). applicable disclosure law. For more
information about FDA’s posting of
SUMMARY: The Food and Drug Written/Paper Submissions
comments and scientific data and
Administration (FDA or we) is Submit written/paper submissions as information to public dockets, see 80 FR
requesting scientific data, information, follows: 56469, September 18, 2015, or access
and comments that would assist the • Mail/Hand delivery/Courier (for
jstallworth on DSK7TPTVN1PROD with NOTICES
the information at: http://www.fda.gov/
Agency in its plan to develop a risk written/paper submissions): Division of regulatoryinformation/dockets/
assessment for produce grown in fields Dockets Management (HFA–305), Food default.htm.
or other growing areas amended with and Drug Administration, 5630 Fishers Docket: For access to the docket to
untreated biological soil amendments of Lane, Rm. 1061, Rockville, MD 20852. read background documents or the
animal origin (including raw manure). • For written/paper comments and electronic and written/paper comments
The risk assessment will evaluate and, scientific data and information and scientific data and information
if feasible, quantify the risk of human submitted to the Division of Dockets received, go to http://
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Document Created: 2018-02-02 15:05:46
Document Modified: 2018-02-02 15:05:46
| 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 3, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 11571 |
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