Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials; Draft Guidance for Industry; Availability; Correction, 50382 [2018-21677]

Download as PDF 50382 Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES 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. Title of Information Collection: Electronic Visit Verification Compliance Survey; Type of Information Collection Request: New collection (request for a new OMB control number); Use: This collection entails an electronic webbased survey that will allow states to self-report their progress in implementing electronic visit verification (EVV) for personal care services (PCS) and home health care services (HHCS), as required by section 1903(l) of the Social Security Act. CMS will use the survey data to assess states’ compliance with section 1903(l) of the Act and levy Federal Medical Assistance Percentage (FMAP) reductions where necessary as required by 1903(l) of the Act. Data collection will begin in November 2019 and will end when all states have fully implemented EVV systems according to the requirements specified at section 1903(l) of the Act. The survey will be disseminated to all 51 state Medicaid agencies (including the District of Columbia) and the Medicaid agencies of five US territories. States will be required to complete the survey in order to demonstrate that they are complaint with Section 1903(l) of the Act by reporting on their EVV implementation status for PCS provided under sections 1905(a)(24), 1915(c), 1915(i), 1915(j), 1915(k), and Section 1115 of the Act; and HHCS provided under 1905(a)(7) of the Act or under a demonstration project or waiver (e.g., 1915(c) or 1115 of the Act). The survey will be a live form, meaning states will have the ability to update their 1903(l) compliance status on a continuous basis. As FMAP reductions are assigned quarterly per 1903(l) of the Act, states who are not in compliance will be asked to review their survey information on a quarterly basis to ensure it is up-to-date and to update their survey responses as needed until they come into compliance. Form Number: CMS–10680 (OMB control VerDate Sep<11>2014 17:11 Oct 04, 2018 Jkt 247001 number: 0938–New); Frequency: On occasion; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Number of Responses: 336; Total Annual Hours: 1,344. (For questions regarding this collection contact Ryan Shannahan at 410–786– 0295.) Dated: October 2, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018–21754 Filed 10–4–18; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–3464] Food and Drug Administration, HHS. Notice of availability; correction. ACTION: The Food and Drug Administration (FDA or we) is correcting a document that appeared in the Federal Register of September 7, 2018 (83 FR 45454). The document announced the draft guidance for industry entitled ‘‘Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.’’ The notice inadvertently contained the wrong docket number. This document corrects that error. SUMMARY: This notice is applicable October 5, 2018. DATES: FOR FURTHER INFORMATION CONTACT: Steven Tave, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2878. In the Federal Register of Friday, September 7, 2018, appearing on page 45454 in FR. Doc. 2018–19367, the following corrections are made: On page 45454, in the docket heading in column 1, the docket number appearing in square brackets is corrected to be FDA–2018–D–3464. On page 45454, in the ‘‘Instructions,’’ in column 2, the Docket No. is corrected to be FDA–2018–D–3464. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 [FR Doc. 2018–21677 Filed 10–4–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–1837] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 5, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0805. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials; Draft Guidance for Industry; Availability; Correction AGENCY: Dated: October 1, 2018. Leslie Kux, Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Electronic User Fee Payment Request Forms—Form FDA 3913 and Form FDA 3914 OMB Control Number 0910–0805— Extension Form FDA 3913, User Fee Payment Refund Request, is designed to provide the minimum necessary information for E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Page 50382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3464]


Policy Regarding Quantitative Labeling of Dietary Supplements 
Containing Live Microbials; Draft Guidance for Industry; Availability; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is correcting a 
document that appeared in the Federal Register of September 7, 2018 (83 
FR 45454). The document announced the draft guidance for industry 
entitled ``Policy Regarding Quantitative Labeling of Dietary 
Supplements Containing Live Microbials.'' The notice inadvertently 
contained the wrong docket number. This document corrects that error.

DATES: This notice is applicable October 5, 2018.

FOR FURTHER INFORMATION CONTACT: Steven Tave, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2878.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, September 
7, 2018, appearing on page 45454 in FR. Doc. 2018-19367, the following 
corrections are made:
    On page 45454, in the docket heading in column 1, the docket number 
appearing in square brackets is corrected to be FDA-2018-D-3464.
    On page 45454, in the ``Instructions,'' in column 2, the Docket No. 
is corrected to be FDA-2018-D-3464.

    Dated: October 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21677 Filed 10-4-18; 8:45 am]
 BILLING CODE 4164-01-P

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