Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms, 50382-50383 [2018-21682]

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 Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices FDA to review and process a user fee payment refund. The information collected includes the organization, contact, and payment information. The information is used to determine the reason for the refund, the refund amount, and who to contact if there are any questions regarding the refund request. A submission of the User Fee Payment Refund Request form does not guarantee that a refund will be issued. FDA estimates an average of 0.40 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. The estimated hours are based on past FDA experience with user fee payment refund requests. In fiscal year 2017, approximately 1,657 user fee refunds were processed for cover sheets and invoices including 12 for Animal Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 13 for Biosimilar Drug User Fee Act, 68 for Export Certificate Program, 14 for Freedom of Information Act requests, 227 for Generic Drug User Fee Amendments, 1,021 for Medical Device User Fee Amendments, 227 for mammography inspection fees, 67 for Prescription Drug User Fee Act, and 6 for tobacco product fees. Form FDA 3914, User Fee Payment Transfer Request, is designed to provide the minimum information necessary for FDA to review and process a user fee payment transfer request. The information collected includes payment and organization information. The information is used to determine the reason for the transfer, how the transfer should be performed, and who to contact if there are any questions regarding the transfer request. A submission of the User Fee Payment Transfer Request form does not guarantee that a transfer will be performed. FDA estimates an average of 0.25 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. FDA estimated hours are based on past FDA experience with user fee payment transfer requests. In fiscal year 2017, approximately 871 user fee payment transfers were processed for cover sheets and invoices including 8 for Animal Drug User Fee Act, 1 for Animal Generic Drug User Fee Act, 1 for Biosimilar Drug User Fee Act, 163 for Generic Drug User Fee Amendments, 692 for Medical Device User Fee Amendments, and 6 for Prescription Drug User Fee Act. Respondents for the electronic request forms include domestic and foreign firms (including pharmaceutical, medical device, etc.). Specifically, refund request forms target respondents 50383 who submitted a duplicate payment or overpayment for a user fee cover sheet or invoice. Respondents may also include firms that withdrew an application or submission. Transfer request forms target respondents who submitted payment for a user fee cover sheet or invoice and need that payment to be reapplied to another cover sheet or invoice (transfer of funds). The electronic user fee payment request forms will streamline the refund and transfer processes, facilitate processing, and improve the tracking of requests. The burden for this collection of information is the same for all customers (small and large organizations). The information being requested or required has been held to the absolute minimum required for the intended use of the data. Customers will be able to request a user fee payment refund and transfer online at https:// www.fda.gov/forindustry/userfees/ default.htm. This electronic submission is intended to reduce the burden for customers to submit user fee payment refund and transfer requests. In the Federal Register of May 15, 2018 (83 FR 22493), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FDA Form Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours User Fee Payment Refund Request—Form FDA 3913 ........ User Fee Payment Transfer Request—Form FDA 3914 ...... Total ................................................................................ 1,657 871 .................... 1 1 ........................ 1,657 871 .................... 0.40 (24 minutes) .... 0.25 (15 minutes) .... ................................. 663 218 881 1 There are no capital costs or operating and maintenance costs associated with this collection of information. daltland on DSKBBV9HB2PROD with NOTICES We have adjusted our burden estimate, which has resulted in a decrease to the currently approved burden. New information technology applications have more accurately calculated the number of registrants of drug facilities/food facilities/medical device facilities/medicated feed facilities, and we have therefore revised the number of respondents to the information collection. Dated: October 1, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–21682 Filed 10–4–18; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:11 Oct 04, 2018 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Applications in Lung Disease. Date: October 30–31, 2018. Time: 9:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: George M. Barnas, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4220, MSC 7818, Bethesda, MD 20892, 301–435– 0696, barnasg@csr.nih.gov. E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50382-50383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21682]


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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.

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

SUMMARY: 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 [email protected]. 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.

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, 
[email protected].

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

[[Page 50383]]

FDA to review and process a user fee payment refund. The information 
collected includes the organization, contact, and payment information. 
The information is used to determine the reason for the refund, the 
refund amount, and who to contact if there are any questions regarding 
the refund request. A submission of the User Fee Payment Refund Request 
form does not guarantee that a refund will be issued. FDA estimates an 
average of 0.40 hours per response, including the time to review 
instructions, search existing data sources, gather and maintain the 
data needed, and complete and review the collection of information. The 
estimated hours are based on past FDA experience with user fee payment 
refund requests.
    In fiscal year 2017, approximately 1,657 user fee refunds were 
processed for cover sheets and invoices including 12 for Animal Drug 
User Fee Act, 2 for Animal Generic Drug User Fee Act, 13 for Biosimilar 
Drug User Fee Act, 68 for Export Certificate Program, 14 for Freedom of 
Information Act requests, 227 for Generic Drug User Fee Amendments, 
1,021 for Medical Device User Fee Amendments, 227 for mammography 
inspection fees, 67 for Prescription Drug User Fee Act, and 6 for 
tobacco product fees.
    Form FDA 3914, User Fee Payment Transfer Request, is designed to 
provide the minimum information necessary for FDA to review and process 
a user fee payment transfer request. The information collected includes 
payment and organization information. The information is used to 
determine the reason for the transfer, how the transfer should be 
performed, and who to contact if there are any questions regarding the 
transfer request. A submission of the User Fee Payment Transfer Request 
form does not guarantee that a transfer will be performed. FDA 
estimates an average of 0.25 hours per response, including the time to 
review instructions, search existing data sources, gather and maintain 
the data needed, and complete and review the collection of information. 
FDA estimated hours are based on past FDA experience with user fee 
payment transfer requests.
    In fiscal year 2017, approximately 871 user fee payment transfers 
were processed for cover sheets and invoices including 8 for Animal 
Drug User Fee Act, 1 for Animal Generic Drug User Fee Act, 1 for 
Biosimilar Drug User Fee Act, 163 for Generic Drug User Fee Amendments, 
692 for Medical Device User Fee Amendments, and 6 for Prescription Drug 
User Fee Act.
    Respondents for the electronic request forms include domestic and 
foreign firms (including pharmaceutical, medical device, etc.). 
Specifically, refund request forms target respondents who submitted a 
duplicate payment or overpayment for a user fee cover sheet or invoice. 
Respondents may also include firms that withdrew an application or 
submission. Transfer request forms target respondents who submitted 
payment for a user fee cover sheet or invoice and need that payment to 
be reapplied to another cover sheet or invoice (transfer of funds).
    The electronic user fee payment request forms will streamline the 
refund and transfer processes, facilitate processing, and improve the 
tracking of requests. The burden for this collection of information is 
the same for all customers (small and large organizations). The 
information being requested or required has been held to the absolute 
minimum required for the intended use of the data. Customers will be 
able to request a user fee payment refund and transfer online at 
https://www.fda.gov/forindustry/userfees/default.htm. This electronic 
submission is intended to reduce the burden for customers to submit 
user fee payment refund and transfer requests.
    In the Federal Register of May 15, 2018 (83 FR 22493), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                               Number of       Total
           FDA Form             Number of    responses per     annual        Average burden per      Total hours
                               respondents    respondent     responses            response
----------------------------------------------------------------------------------------------------------------
User Fee Payment Refund              1,657               1        1,657  0.40 (24 minutes).........          663
 Request--Form FDA 3913.
User Fee Payment Transfer              871               1          871  0.25 (15 minutes).........          218
 Request--Form FDA 3914.
    Total....................  ...........  ..............  ...........  ..........................          881
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have adjusted our burden estimate, which has resulted in a 
decrease to the currently approved burden. New information technology 
applications have more accurately calculated the number of registrants 
of drug facilities/food facilities/medical device facilities/medicated 
feed facilities, and we have therefore revised the number of 
respondents to the information collection.

    Dated: October 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21682 Filed 10-4-18; 8:45 am]
 BILLING CODE 4164-01-P