83_FR_50576 83 FR 50382 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms

83 FR 50382 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 194 (October 5, 2018)

Page Range50382-50383
FR Document2018-21682

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.

Federal Register, Volume 83 Issue 194 (Friday, October 5, 2018) 
[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50382-50383]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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 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.

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

[[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

50382 Federal Register / Vol. 83, No. 194 / Friday, October 5, 2018 / Notices defined in 44 U.S.C. 3502(3) and 5 CFR number: 0938–New); Frequency: On Dated: October 1, 2018. 1320.3(c) and includes agency requests occasion; Affected Public: State, Local, Leslie Kux, or requirements that members of the or Tribal Governments; Number of Associate Commissioner for Policy. public submit reports, keep records, or Respondents: 56; Number of Responses: [FR Doc. 2018–21677 Filed 10–4–18; 8:45 am] provide information to a third party. 336; Total Annual Hours: 1,344. (For BILLING CODE 4164–01–P Section 3506(c)(2)(A) of the PRA questions regarding this collection requires federal agencies to publish a contact Ryan Shannahan at 410–786– 60-day notice in the Federal Register 0295.) DEPARTMENT OF HEALTH AND concerning each proposed collection of Dated: October 2, 2018. HUMAN SERVICES information, including each proposed William N. Parham, III, extension or reinstatement of an existing Food and Drug Administration collection of information, before Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory [Docket No. FDA–2015–N–1837] submitting the collection to OMB for Affairs. approval. To comply with this Agency Information Collection requirement, CMS is publishing this [FR Doc. 2018–21754 Filed 10–4–18; 8:45 am] Activities; Submission for Office of notice. BILLING CODE 4120–01–P Management and Budget Review; Information Collection Comment Request; Electronic User 1. Title of Information Collection: DEPARTMENT OF HEALTH AND Fee Payment Request Forms Electronic Visit Verification Compliance HUMAN SERVICES AGENCY: Food and Drug Administration, Survey; Type of Information Collection HHS. Request: New collection (request for a Food and Drug Administration ACTION: Notice. new OMB control number); Use: This collection entails an electronic web- [Docket No. FDA–2018–D–3464] SUMMARY: The Food and Drug based survey that will allow states to Administration (FDA) is announcing self-report their progress in Policy Regarding Quantitative Labeling that a proposed collection of implementing electronic visit of Dietary Supplements Containing information has been submitted to the verification (EVV) for personal care Live Microbials; Draft Guidance for Office of Management and Budget services (PCS) and home health care Industry; Availability; Correction (OMB) for review and clearance under services (HHCS), as required by section the Paperwork Reduction Act of 1995. 1903(l) of the Social Security Act. CMS AGENCY: Food and Drug Administration, DATES: Fax written comments on the will use the survey data to assess states’ HHS. collection of information by November compliance with section 1903(l) of the ACTION: Notice of availability; 5, 2018. Act and levy Federal Medical correction. Assistance Percentage (FMAP) ADDRESSES: To ensure that comments on reductions where necessary as required the information collection are received, SUMMARY: The Food and Drug OMB recommends that written by 1903(l) of the Act. Data collection Administration (FDA or we) is comments be faxed to the Office of will begin in November 2019 and will correcting a document that appeared in Information and Regulatory Affairs, end when all states have fully implemented EVV systems according to the Federal Register of September 7, OMB, Attn: FDA Desk Officer, Fax: 202– the requirements specified at section 2018 (83 FR 45454). The document 395–7285, or emailed to oira_ 1903(l) of the Act. announced the draft guidance for submission@omb.eop.gov. All The survey will be disseminated to all industry entitled ‘‘Policy Regarding comments should be identified with the 51 state Medicaid agencies (including Quantitative Labeling of Dietary OMB control number 0910–0805. Also the District of Columbia) and the Supplements Containing Live include the FDA docket number found Medicaid agencies of five US territories. Microbials.’’ The notice inadvertently in brackets in the heading of this States will be required to complete the contained the wrong docket number. document. survey in order to demonstrate that they This document corrects that error. FOR FURTHER INFORMATION CONTACT: are complaint with Section 1903(l) of DATES: This notice is applicable October JonnaLynn Capezzuto, Office of the Act by reporting on their EVV 5, 2018. Operations, Food and Drug implementation status for PCS provided Administration, Three White Flint under sections 1905(a)(24), 1915(c), FOR FURTHER INFORMATION CONTACT: Steven Tave, Center for Food Safety and North, 10A–12M, 11601 Landsdown St., 1915(i), 1915(j), 1915(k), and Section North Bethesda, MD 20852, 301–796– 1115 of the Act; and HHCS provided Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 3794, PRAStaff@fda.hhs.gov. under 1905(a)(7) of the Act or under a College Park, MD 20740, 240–402–2878. SUPPLEMENTARY INFORMATION: In demonstration project or waiver (e.g., compliance with 44 U.S.C. 3507, FDA 1915(c) or 1115 of the Act). SUPPLEMENTARY INFORMATION: In the The survey will be a live form, has submitted the following proposed Federal Register of Friday, September 7, collection of information to OMB for meaning states will have the ability to 2018, appearing on page 45454 in FR. update their 1903(l) compliance status review and clearance. Doc. 2018–19367, the following on a continuous basis. As FMAP corrections are made: Electronic User Fee Payment Request reductions are assigned quarterly per Forms—Form FDA 3913 and Form FDA daltland on DSKBBV9HB2PROD with NOTICES 1903(l) of the Act, states who are not in On page 45454, in the docket heading 3914 compliance will be asked to review their in column 1, the docket number survey information on a quarterly basis appearing in square brackets is OMB Control Number 0910–0805— to ensure it is up-to-date and to update corrected to be FDA–2018–D–3464. Extension their survey responses as needed until On page 45454, in the ‘‘Instructions,’’ Form FDA 3913, User Fee Payment they come into compliance. Form in column 2, the Docket No. is corrected Refund Request, is designed to provide Number: CMS–10680 (OMB control to be FDA–2018–D–3464. the minimum necessary information for VerDate Sep<11>2014 17:11 Oct 04, 2018 Jkt 247001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1

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


Document Created: 2018-10-05 01:52:50
Document Modified: 2018-10-05 01:52:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by November 5, 2018.
ContactJonnaLynn 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]
FR Citation83 FR 50382 
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