82 FR 47747 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 197 (October 13, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 197 (October 13, 2017)
| Page Range | 47747-47748 | |
| FR Document | 2017-22207 |
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)] [Notices] [Pages 47747-47748] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22207] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10305] 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 December 12, 2017. 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: 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 and associated materials (see ADDRESSES). CMS-10305 Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) 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: Revision of a currently approved collection; Title of Information Collection: Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)); Use: Medicare Part C and Part D sponsoring organizations (Medicare Advantage Organizations), must submit Medicare Part C, Medicare Part D, or Medicare Part C and Part D data (depending on the type of contracts they have in place with CMS). In order for the reported data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations. To maintain the independence of the validation process, sponsoring organizations are responsible for hiring external, independent data validation contractors (DVCs) who meet a minimum set of qualifications and credentials. For the retrospective review in 2018, the DVCs will review data submitted by sponsoring organizations for CY2017. The main changes for the 2018 DV are to eliminate the Part C/D reporting section Sponsor Oversight of Agents and adding the Part D reporting section Improving Drug Utilization Review [[Page 47748]] Controls. Form Number: CMS-10305 (OMB control number: 0938-1115); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 574; Total Annual Responses: 574; Total Annual Hours: 24,050. (For policy questions regarding this collection contact Maria Sotirelis at 410-786-0552.) Dated: October 10, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017-22207 Filed 10-12-17; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 47747
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Injury Control Research Center (ICRC) Grant- ICRC Indicators Data Collection .................... 10 1 20
ees.
(ICRC) Grantees ............................................. ICRC Indicators Data Collection: Non-CDC 10 1 10
Study Supplement.
ICRC Personnel and Publication Excel Data 10 1 20
Collection.
Leroy A. Richardson, ADDRESSES: When commenting, please approval from the Office of Management
Chief, Information Collection Review Office, reference the document identifier or and Budget (OMB) for each collection of
Office of Scientific Integrity, Office of the OMB control number. To be assured information they conduct or sponsor.
Associate Director for Science, Office of the consideration, comments and The term ‘‘collection of information’’ is
Director, Centers for Disease Control and recommendations must be submitted in defined in 44 U.S.C. 3502(3) and 5 CFR
Prevention. any one of the following ways: 1320.3(c) and includes agency requests
[FR Doc. 2017–22197 Filed 10–12–17; 8:45 am] 1. Electronically. You may send your or requirements that members of the
BILLING CODE 4163–18–P comments electronically to http:// public submit reports, keep records, or
www.regulations.gov. Follow the provide information to a third party.
instructions for ‘‘Comment or Section 3506(c)(2)(A) of the PRA
DEPARTMENT OF HEALTH AND Submission’’ or ‘‘More Search Options’’ requires federal agencies to publish a
HUMAN SERVICES to find the information collection 60-day notice in the Federal Register
document(s) that are accepting concerning each proposed collection of
Centers for Medicare & Medicaid comments.
Services information, including each proposed
2. By regular mail. You may mail extension or reinstatement of an existing
written comments to the following collection of information, before
[Document Identifier: CMS–10305] address: CMS, Office of Strategic submitting the collection to OMB for
Operations and Regulatory Affairs, approval. To comply with this
Agency Information Collection Division of Regulations Development, requirement, CMS is publishing this
Activities: Proposed Collection; Attention: Document Identifier/OMB notice.
Comment Request Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore, Information Collection
AGENCY: Centers for Medicare &
Medicaid Services, HHS. Maryland 21244–1850.
To obtain copies of a supporting 1. Type of Information Collection
ACTION: Notice. statement and any related forms for the Request: Revision of a currently
proposed collection(s) summarized in approved collection; Title of
SUMMARY: The Centers for Medicare & Information Collection: Medicare Part C
Medicaid Services (CMS) is announcing this notice, you may make your request
using one of following: and Part D Data Validation (42 CFR
an opportunity for the public to 422.516(g) and 423.514(g)); Use:
1. Access CMS’ Web site address at
comment on CMS’ intention to collect Medicare Part C and Part D sponsoring
http://www.cms.hhs.gov/
information from the public. Under the organizations (Medicare Advantage
PaperworkReductionActof1995.
Paperwork Reduction Act of 1995 (the Organizations), must submit Medicare
2. Email your request, including your
PRA), federal agencies are required to Part C, Medicare Part D, or Medicare
address, phone number, OMB number,
publish notice in the Federal Register Part C and Part D data (depending on
and CMS document identifier, to
concerning each proposed collection of the type of contracts they have in place
Paperwork@cms.hhs.gov.
information (including each proposed 3. Call the Reports Clearance Office at with CMS). In order for the reported
extension or reinstatement of an existing (410) 786–1326. data to be useful for monitoring and
collection of information) and to allow performance measurement, the data
FOR FURTHER INFORMATION CONTACT:
60 days for public comment on the must be reliable, valid, complete, and
William Parham at (410) 786–4669.
proposed action. Interested persons are comparable among sponsoring
SUPPLEMENTARY INFORMATION:
invited to send comments regarding our organizations. To maintain the
burden estimates or any other aspect of Contents independence of the validation process,
this collection of information, including This notice sets out a summary of the sponsoring organizations are
the necessity and utility of the proposed use and burden associated with the responsible for hiring external,
information collection for the proper following information collections. More independent data validation contractors
performance of the agency’s functions, detailed information can be found in (DVCs) who meet a minimum set of
the accuracy of the estimated burden,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
each collection’s supporting statement qualifications and credentials. For the
ways to enhance the quality, utility, and and associated materials (see retrospective review in 2018, the DVCs
clarity of the information to be ADDRESSES). will review data submitted by
collected, and the use of automated sponsoring organizations for CY2017.
collection techniques or other forms of CMS–10305 Medicare Part C and Part The main changes for the 2018 DV are
information technology to minimize the D Data Validation (42 CFR 422.516(g) to eliminate the Part C/D reporting
information collection burden. and 423.514(g)) section Sponsor Oversight of Agents and
DATES: Comments must be received by Under the PRA (44 U.S.C. 3501– adding the Part D reporting section
December 12, 2017. 3520), federal agencies must obtain Improving Drug Utilization Review
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![47748 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices
Controls. Form Number: CMS–10305 comment does not include any contact information to be made publicly
(OMB control number: 0938–1115); confidential information that you or a available, you can provide this
Frequency: Yearly; Affected Public: third party may not wish to be posted, information on the cover sheet and not
Private sector (Business or other for- such as medical information, your or in the body of your comments and you
profits); Number of Respondents: 574; anyone else’s Social Security number, or must identify this information as
Total Annual Responses: 574; Total confidential business information, such ‘‘confidential.’’ Any information marked
Annual Hours: 24,050. (For policy as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
questions regarding this collection that if you include your name, contact except in accordance with 21 CFR 10.20
contact Maria Sotirelis at 410–786– information, or other information that and other applicable disclosure law. For
0552.) identifies you in the body of your more information about FDA’s posting
Dated: October 10, 2017.
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
William N. Parham, III,
• If you want to submit a comment the information at: https://www.gpo.gov/
Director, Paperwork Reduction Staff, Office with confidential information that you
of Strategic Operations and Regulatory
fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Affairs.
public, submit the comment as a Docket: For access to the docket to
[FR Doc. 2017–22207 Filed 10–12–17; 8:45 am]
written/paper submission and in the read background documents or the
BILLING CODE 4120–01–P manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
DEPARTMENT OF HEALTH AND Written/Paper Submissions www.regulations.gov and insert the
HUMAN SERVICES docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
Food and Drug Administration • Mail/Hand delivery/Courier (for
and/or go to the Dockets Management
[Docket No. FDA–2017–D–5913] written/paper submissions): Dockets
Staff, 5630 Fishers Lane, Rm. 1061,
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Drug Administration, 5630 Fishers
Prescription Drug User Fee You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852.
Amendments of 2017; Draft Guidance • For written/paper comments guidance at any time (see 21 CFR
for Industry; Availability submitted to the Dockets Management 10.115(g)(5)).
Staff, FDA will post your comment, as Submit written requests for single
AGENCY: Food and Drug Administration, well as any attachments, except for copies of the draft guidance to the
HHS. information submitted, marked and Division of Drug Information, Center for
ACTION: Notice of availability. identified, as confidential, if submitted Drug Evaluation and Research, Food
as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New
SUMMARY: The Food and Drug Hampshire Ave., Hillandale Building,
Instructions: All submissions received
Administration (FDA or Agency) is 4th Floor, Silver Spring, MD 20993–
must include the Docket No. FDA–
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‘‘Assessing User Fees Under the Development, Center for Biologics
Amendments of 2017; Draft Guidance
Prescription Drug User Fee Evaluation and Research, Food and
for Industry.’’ Received comments will
Amendments of 2017.’’ This draft Drug Administration, 10903 New
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implementation of the Prescription Drug Silver Spring, MD 20993–0002. Send
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certain proposed changes in policies assist the office in processing your
Dockets Management Staff between 9
and procedures surrounding its requests. See the SUPPLEMENTARY
a.m. and 4 p.m., Monday through
application. INFORMATION section for electronic
Friday.
DATES: Submit either electronic or • Confidential Submissions—To access to the draft guidance document.
written comments on the draft guidance submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
by December 12, 2017 to ensure that the information that you do not wish to be Peter Chen, Center for Drug Evaluation
Agency considers your comment on this made publicly available, submit your and Research, Food and Drug
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Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The New Hampshire Ave., Bldg. 71, Rm.
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asabaliauskas on DSKBBXCHB2PROD with NOTICES
the claimed confidential information, in
https://www.regulations.gov. Follow the its consideration of comments. The SUPPLEMENTARY INFORMATION:
instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information I. Background
including attachments, to https:// redacted/blacked out, will be available FDA is announcing the availability of
www.regulations.gov will be posted to for public viewing and posted on a draft guidance for industry entitled
the docket unchanged. Because your https://www.regulations.gov. Submit ‘‘Assessing User Fees Under the
comment will be made public, you are both copies to the Dockets Management Prescription Drug User Fee
solely responsible for ensuring that your Staff. If you do not wish your name and Amendments of 2017.’’ This draft
VerDate Sep<11>2014 18:05 Oct 12, 2017 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1](https://thefederalregister.org/doc/82_FR_47944/page/2.svg)
Document Created: 2017-10-13 04:33:49
Document Modified: 2017-10-13 04:33:49
| 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 December 12, 2017. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 47747 |
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