83 FR 2785 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 13 (January 19, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 13 (January 19, 2018)
| Page Range | 2785-2786 | |
| FR Document | 2018-00832 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Notices] [Pages 2785-2786] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00832] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10390] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. 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 March 20, 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 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-10390 Hospice Quality Reporting Program 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 Type of Information Collection Request: Extension of a currently approved collection without change; Title of Information Collection: Hospice Quality Reporting Program; Use: The Hospice Item Set (HIS) is a standardized, patient-level data collection tool developed specifically for use by hospices. It is currently used for the collection of quality measure data pertaining to the Hospice Quality Reporting Program (HQRP). Since April 1, 2017, hospices have been using the HIS V2.00.0 which specifies the collection of data items that support eight National Quality Forum (NQF) endorsed Quality Measures (QMs) and an additional measure pair for hospice. All Medicare-certified hospice providers are required to submit HIS admission and discharge records to CMS for each patient admission and discharge. The HIS contains data elements that are used by the CMS to calculate these measures and also allows CMS to collect quality data from hospices in compliance with Section 3004 of the Affordable Care Act. Form Number: CMS-10390 (OMB control number: 0938-1153); Frequency: On Occasion; Affected Public: State, Local, or Tribal Governments, Private Sector (not-for-profit institutions); individuals or households; Number of Respondents: 4,259; Total Annual Responses: 4,259; Total Annual Hours: 686,630. For policy questions regarding this collection contact Cindy Massuda at (410) 786- 0652. [[Page 2786]] Dated: January 12, 2018. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-00832 Filed 1-18-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2785
was no use of seclusion and the only information (including each proposed and associated materials (see
restraint was 2-point soft wrist restraints extension or reinstatement of an existing ADDRESSES).
beginning in May 9, 2014. This collection of information) and to allow
reporting requirement change resulted 60 days for public comment on the CMS–10390 Hospice Quality
in no necessary edits to the form CMS– proposed action. Interested persons are Reporting Program
10455 as soft wrist restraints may be invited to send comments regarding our Under the PRA (44 U.S.C. 3501–
used in combination with other types of burden estimates or any other aspect of 3520), federal agencies must obtain
restraints. It was estimated that this this collection of information, including approval from the Office of Management
would reduce the volume of reports that the necessity and utility of the proposed and Budget (OMB) for each collection of
must be submitted by 90 percent for information collection for the proper information they conduct or sponsor.
hospitals. In addition, the final rule performance of the agency’s functions, The term ‘‘collection of information’’ is
replaced the previous requirement for the accuracy of the estimated burden, defined in 44 U.S.C. 3502(3) and 5 CFR
reporting via telephone to CMS, which ways to enhance the quality, utility, and 1320.3(c) and includes agency requests
proved to be cumbersome for both CMS clarity of the information to be or requirements that members of the
and hospitals, with a requirement that collected, and the use of automated
allows submission of reports via public submit reports, keep records, or
collection techniques or other forms of provide information to a third party.
telephone, facsimile or electronically, as information technology to minimize the
determined by CMS. Section 3506(c)(2)(A) of the PRA
information collection burden. requires federal agencies to publish a
Form CMS–10455 is being revised in
DATES: Comments must be received by 60-day notice in the Federal Register
order to obtain the necessary
March 20, 2018. concerning each proposed collection of
information for the ROs to make a
determination whether or not to ADDRESSES: When commenting, please information, including each proposed
authorize an on-site investigation reference the document identifier or extension or reinstatement of an existing
related to the details surrounding the OMB control number. To be assured collection of information, before
death of individuals associated with consideration, comments and submitting the collection to OMB for
restraint and/or seclusion. Form recommendations must be submitted in approval. To comply with this
Number: CMS–10455 (OMB control any one of the following ways: requirement, CMS is publishing this
number: 0938–1210); Frequency: 1. Electronically. You may send your notice.
Occasionally; Affected Public: Private comments electronically to http://
www.regulations.gov. Follow the Information Collection
Sector; Number of Respondents: 6,389;
Number of Responses: 6,389; Total instructions for ‘‘Comment or Type of Information Collection
Annual Hours: 2,619. (For policy Submission’’ or ‘‘More Search Options’’ Request: Extension of a currently
questions regarding this collection to find the information collection approved collection without change;
contact Karina Meushaw at 410–786– document(s) that are accepting Title of Information Collection: Hospice
1000.) comments. Quality Reporting Program; Use: The
Dated: January 12, 2018. 2. By regular mail. You may mail Hospice Item Set (HIS) is a
written comments to the following standardized, patient-level data
Martique Jones,
address: CMS, Office of Strategic collection tool developed specifically
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Operations and Regulatory Affairs, for use by hospices. It is currently used
Affairs. Division of Regulations Development, for the collection of quality measure
[FR Doc. 2018–00834 Filed 1–18–18; 8:45 am]
Attention: Document Identifier/OMB data pertaining to the Hospice Quality
Control Number lll, Room C4–26– Reporting Program (HQRP). Since April
BILLING CODE 4120–01–P
05, 7500 Security Boulevard, Baltimore, 1, 2017, hospices have been using the
Maryland 21244–1850. HIS V2.00.0 which specifies the
DEPARTMENT OF HEALTH AND To obtain copies of a supporting collection of data items that support
HUMAN SERVICES statement and any related forms for the eight National Quality Forum (NQF)
proposed collection(s) summarized in endorsed Quality Measures (QMs) and
Centers for Medicare & Medicaid this notice, you may make your request an additional measure pair for hospice.
Services using one of following: All Medicare-certified hospice providers
1. Access CMS’ website address at are required to submit HIS admission
[Document Identifier: CMS–10390]
http://www.cms.hhs.gov/ and discharge records to CMS for each
Agency Information Collection PaperworkReductionActof1995. patient admission and discharge. The
Activities: Proposed Collection; 2. Email your request, including your HIS contains data elements that are used
Comment Request address, phone number, OMB number, by the CMS to calculate these measures
and CMS document identifier, to and also allows CMS to collect quality
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov.
Medicaid Services, Department of data from hospices in compliance with
3. Call the Reports Clearance Office at Section 3004 of the Affordable Care Act.
Health and Human Services. (410) 786–1326. Form Number: CMS–10390 (OMB
ACTION: Notice.
FOR FURTHER INFORMATION CONTACT: control number: 0938–1153); Frequency:
SUMMARY: The Centers for Medicare & William Parham at (410) 786–4669. On Occasion; Affected Public: State,
Medicaid Services (CMS) is announcing SUPPLEMENTARY INFORMATION: Local, or Tribal Governments, Private
daltland on DSKBBV9HB2PROD with NOTICES
an opportunity for the public to Sector (not-for-profit institutions);
comment on CMS’ intention to collect Contents individuals or households; Number of
information from the public. Under the This notice sets out a summary of the Respondents: 4,259; Total Annual
Paperwork Reduction Act of 1995 (the use and burden associated with the Responses: 4,259; Total Annual Hours:
PRA), federal agencies are required to following information collections. More 686,630. For policy questions regarding
publish notice in the Federal Register detailed information can be found in this collection contact Cindy Massuda at
concerning each proposed collection of each collection’s supporting statement (410) 786–0652.
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![2786 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
Dated: January 12, 2018. anyone else’s Social Security number, or in the body of your comments and you
Martique Jones, confidential business information, such must identify this information as
Director, Regulations Development Group, as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Office of Strategic Operations and Regulatory that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Affairs. information, or other information that except in accordance with 21 CFR 10.20
[FR Doc. 2018–00832 Filed 1–18–18; 8:45 am] identifies you in the body of your and other applicable disclosure law. For
BILLING CODE 4120–01–P comments, that information will be more information about FDA’s posting
posted on https://www.regulations.gov. of comments to public dockets, see 80
• If you want to submit a comment FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND with confidential information that you the information at: https://www.gpo.gov/
HUMAN SERVICES do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf.
Food and Drug Administration written/paper submission and in the Docket: For access to the docket to
[Docket No. FDA–2016–D–1267] manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Compounded Drug Products That Are received, go to https://
Written/Paper Submissions
Essentially Copies of Approved Drug www.regulations.gov and insert the
Products Under Section 503B of the Submit written/paper submissions as docket number, found in brackets in the
Federal Food, Drug, and Cosmetic Act; follows: heading of this document, into the
Guidance for Industry; Availability • Mail/Hand Delivery/Courier (for ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets and/or go to the Dockets Management
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
HHS. Drug Administration, 5630 Fishers Rockville, MD 20852.
ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any
• For written/paper comments guidance at any time (see 21 CFR
SUMMARY: The Food and Drug submitted to the Dockets Management 10.115(g)(5)).
Administration (FDA or Agency) is Staff, FDA will post your comment, as Submit written requests for single
announcing the availability of a well as any attachments, except for copies of the guidance to the Division of
guidance for industry entitled information submitted, marked and Drug Information, Center for Drug
‘‘Compounded Drug Products That Are identified, as confidential, if submitted Evaluation and Research, Food and
Essentially Copies of Approved Drug as detailed in ‘‘Instructions.’’ Drug Administration, 10001 New
Products Under Section 503B of the Instructions: All submissions received Hampshire Ave., Hillandale Building,
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For a drug product compounded by an 2016–D–1267 for ‘‘Compounded Drug 0002. Send one self-addressed adhesive
outsourcing facility to qualify for the Products That Are Essentially Copies of label to assist that office in processing
exemptions under section 503B of the Approved Drug Products Under Section your requests. See the SUPPLEMENTARY
Federal Food, Drug, and Cosmetic Act 503B of the Federal Food, Drug, and INFORMATION section for electronic
(FD&C Act), it must not be essentially a Cosmetic Act.’’ Received comments will access to the guidance document.
copy of one or more approved drug be placed in the docket and, except for FOR FURTHER INFORMATION CONTACT: Sara
products and must meet other those submitted as ‘‘Confidential Rothman, Center for Drug Evaluation
conditions in section 503B. This Submissions,’’ publicly viewable at and Research, Food and Drug
guidance sets forth FDA’s policies https://www.regulations.gov or at the Administration, 10903 New Hampshire
concerning the ‘‘essentially a copy’’ Dockets Management Staff between 9 Ave., Bldg. 51, Rm. 5197, Silver Spring,
provision of section 503B of the FD&C a.m. and 4 p.m., Monday through MD 20993, 301–796–3110.
Act. Friday. SUPPLEMENTARY INFORMATION:
DATES: The announcement of the • Confidential Submissions—To
guidance is published in the Federal submit a comment with confidential I. Background
Register on January 19, 2018. information that you do not wish to be FDA is announcing the availability of
ADDRESSES: You may submit either made publicly available, submit your a guidance for industry entitled
electronic or written comments on comments only as a written/paper ‘‘Compounded Drug Products That Are
Agency guidances at any time as submission. You should submit two Essentially Copies of Approved Drug
follows: copies total. One copy will include the Products Under Section 503B of the
information you claim to be confidential Federal Food, Drug, and Cosmetic Act.’’
Electronic Submissions with a heading or cover note that states In 2013, the Drug Quality and Security
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Act, created new section 503B of the
following way: CONFIDENTIAL INFORMATION.’’ The FD&C Act (21 U.S.C. 353b), which
• Federal eRulemaking Portal: Agency will review this copy, including describes a new category of
https://www.regulations.gov. Follow the the claimed confidential information, in compounders called outsourcing
instructions for submitting comments. its consideration of comments. The facilities. Section 503B of the FD&C Act
Comments submitted electronically, second copy, which will have the describes the conditions that must be
including attachments, to https:// claimed confidential information satisfied for human drug products
www.regulations.gov will be posted to redacted/blacked out, will be available compounded by or under the direct
daltland on DSKBBV9HB2PROD with NOTICES
the docket unchanged. Because your for public viewing and posted on supervision of a licensed pharmacist in
comment will be made public, you are https://www.regulations.gov. Submit an outsourcing facility to qualify for
solely responsible for ensuring that your both copies to the Dockets Management exemptions from the following three
comment does not include any Staff. If you do not wish your name and sections of the FD&C Act:
confidential information that you or a contact information to be made publicly • Section 502(f)(1) (21 U.S.C.
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such as medical information, your or information on the cover sheet and not with adequate directions for use);
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Document Created: 2018-01-19 02:42:41
Document Modified: 2018-01-19 02:42:41
| 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 March 20, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 2785 |
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