Agency Information Collection Activities: Proposed Collection; Comment Request, 2785-2786 [2018-00832]

Download as PDF Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices was no use of seclusion and the only restraint was 2-point soft wrist restraints beginning in May 9, 2014. This reporting requirement change resulted in no necessary edits to the form CMS– 10455 as soft wrist restraints may be used in combination with other types of restraints. It was estimated that this would reduce the volume of reports that must be submitted by 90 percent for hospitals. In addition, the final rule replaced the previous requirement for reporting via telephone to CMS, which proved to be cumbersome for both CMS and hospitals, with a requirement that allows submission of reports via telephone, facsimile or electronically, as determined by CMS. Form CMS–10455 is being revised in order to obtain the necessary information for the ROs to make a determination whether or not to authorize an on-site investigation related to the details surrounding the death of individuals associated with restraint and/or seclusion. Form Number: CMS–10455 (OMB control number: 0938–1210); Frequency: Occasionally; Affected Public: Private Sector; Number of Respondents: 6,389; Number of Responses: 6,389; Total Annual Hours: 2,619. (For policy questions regarding this collection contact Karina Meushaw at 410–786– 1000.) Dated: January 12, 2018. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018–00834 Filed 1–18–18; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10390] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. AGENCY: 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 daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 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 https:// 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 lll, 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.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: 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 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 2785 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. E:\FR\FM\19JAN1.SGM 19JAN1 2786 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–1267] Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ‘‘Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it must not be essentially a copy of one or more approved drug products and must meet other conditions in section 503B. This guidance sets forth FDA’s policies concerning the ‘‘essentially a copy’’ provision of section 503B of the FD&C Act. DATES: The announcement of the guidance is published in the Federal Register on January 19, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or VerDate Sep<11>2014 17:05 Jan 18, 2018 Jkt 244001 anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–D–1267 for ‘‘Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301–796–3110. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ In 2013, the Drug Quality and Security Act, created new section 503B of the FD&C Act (21 U.S.C. 353b), which describes a new category of compounders called outsourcing facilities. Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from the following three sections of the FD&C Act: • Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning labeling of drugs with adequate directions for use); E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2785-2786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00832]


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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 
https://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.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

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