80 FR 57621 - 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 80, Issue 185 (September 24, 2015)

Page Range		57621-57623
FR Document		2015-24228

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 80 Issue 185 (Thursday, September 24, 2015)

[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57621-57623]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24228]


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

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 October 
26, 2015.

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 title Electronic User Fee 
Payment Request Forms. Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455

[[Page 57622]]

Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, 
[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--(OMB Control Number 0910--
NEW)

    The Government Paperwork Elimination Act (GPEA) (Pub. L. 105-277, 
title XVII), was signed into law on October 21, 1998. GPEA requires 
Federal Agencies to allow individuals or entities that deal with the 
Agencies the option to submit information or transact business with the 
Agency electronically, when practicable, and to maintain records 
electronically, when practicable. Its goal is to encourage Agencies to 
incorporate technologically improved respondent reporting, as this 
process typically lowers the burden on the respondent. GPEA allows FDA 
to collect information relating to a user fee payment refund request 
and transfer request.
    Form FDA 3913, User Fee Payment Refund Request, is designed to 
provide the minimum necessary information for 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 the user fee payment refund 
request.
    In fiscal year 2014, approximately 1,741 user fee refunds were 
processed for cover sheets and invoices including 27 for Animal Drug 
User Fee Act, 5 for Animal Generic Drug User Fee Act, 3 for Biosimilar 
Drug User Fee Act, 1 for a Center for Tobacco Products Civil Money 
Penalties, 216 for Export Certificate Program, 79 for Freedom of 
Information Act requests, 523 for Generic Drug User Fee Amendments, 539 
for Medical Device User Fee Amendments, 266 for Mammography inspection 
fee, 81 for Prescription Drug User Fee Act, and 1 for a Tobacco product 
fee.
    Form FDA 3914, User Fee Payment Transfer Request, is designed to 
provide the minimum necessary information 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 the user fee 
payment transfer request.
    In fiscal year 2014, approximately 1,291 user fee payment transfers 
were processed for cover sheets and invoices including 21 for Animal 
Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 544 for 
Generic Drug User Fee Amendments, 627 for Medical Device User Fee 
Amendments, and 97 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 re-applied 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 http://www.fda.gov/forindustry/userfees/default.htm. This electronic 
submission is intended to reduce the burden for customers to submit a 
user fee payment refund and transfer request.
    In the Federal Register of June 26, 2015 (80 FR 36822), 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
               21 CFR section                    Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
User Fee Payment Refund Request--Form FDA              1,700               1           1,700  0.40 (24 minutes).........................             680
 3913.
User Fee Payment Transfer Request--Form FDA            1,700               1           1,700  0.25 (15 minutes).........................             425
 3914.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................            1105
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 57623]]

    Dated: September 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24228 Filed 9-23-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 57621

DC 20447, Attn: ACF Reports Clearance ADDRESSES: Submit electronic www.regulations.gov or written
Officer. All requests should be comments on the interim report to comments to the Division of Dockets
identified by the title of the information http://www.regulations.gov. Submit Management (see ADDRESSES). It is only
collection. Email address: written comments to the Division of necessary to send one set of comments.
infocollection@acf.hhs.gov. Dockets Management (HFA–305), Food Identify comments with the docket
OMB Comment: and Drug Administration, 5630 Fishers number found in brackets in the
OMB is required to make a decision Lane, Rm. 1061, Rockville, MD 20852. heading of this document. Received
concerning the collection of information FOR FURTHER INFORMATION CONTACT: comments may be seen in the Division
between 30 and 60 days after Mark Ascione, Center for Drug of Dockets Management between 9 a.m.
publication of this document in the Evaluation and Research, Food and and 4 p.m., Monday through Friday, and
Federal Register. Therefore, a comment Drug Administration, 10903 New will be posted to the docket at http://
is best assured of having its full effect Hampshire Ave., Bldg. 51, Rm. 1150, www.regulations.gov.
if OMB receives it within 30 days of Silver Spring, MD 20993–0002, 301–
publication. Written comments and III. Electronic Access
796–7652, FAX: 301–847–8443.
recommendations for the proposed The interim report can be accessed at
SUPPLEMENTARY INFORMATION:
information collection should be sent http://www.fda.gov/downloads/
directly to the following: Office of I. Background ForIndustry/UserFees/
Management and Budget, Paperwork BiosimilarUserFeeActBsUFA/
The Patient Protection and Affordable
Reduction Project, Email: OIRA_ UCM459686.pdf.
Care Act of 2010 (Pub. L. 111–148)
SUBMISSION@OMB.EOP.GOV, Attn: amended the Public Health Service Act Dated: September 18, 2015.
Desk Officer for the Administration for to create an abbreviated licensure Leslie Kux,
Children and Families. pathway for biological products that are Associate Commissioner for Policy.
Robert Sargis, demonstrated to be ‘‘biosimilar’’ to or [FR Doc. 2015–24227 Filed 9–23–15; 8:45 am]
Reports Clearance Officer. ‘‘interchangeable’’ with an FDA- BILLING CODE 4164–01–P
[FR Doc. 2015–24270 Filed 9–23–15; 8:45 am] licensed biological product. The Federal
BILLING CODE 4184–01–P
Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by BsUFA (Title DEPARTMENT OF HEALTH AND
IV of the Food and Drug Administration HUMAN SERVICES
DEPARTMENT OF HEALTH AND Safety and Innovation Act, Pub. L. 112–
HUMAN SERVICES 144), authorizes FDA to assess and Food and Drug Administration
collect fees for biosimilar biological [Docket No. FDA–2015–N–1837]
Food and Drug Administration products from October 2012 through
September 2017. FDA uses these fees to Agency Information Collection
[Docket No. FDA–2015–N–3155]
expedite the review process for Activities; Submission for Office of
Interim Results of Study of Workload biosimilar biological products. Management and Budget Review;
Volume and Full Costs Associated Biosimilar biological products represent Comment Request; Electronic User
With Review of Biosimilar Biological an important public health benefit, with Fee Payment Request Forms
Product Applications the potential to offer life-saving or life-
altering benefits at reduced cost to the AGENCY: Food and Drug Administration,
AGENCY: Food and Drug Administration, patient. BsUFA facilitates the HHS.
HHS. development of safe and effective ACTION: Notice.
ACTION: Notice; request for comments. biosimilar products for the American
SUMMARY: The Food and Drug
public.
SUMMARY: The Food and Drug Administration (FDA) is announcing
As part of BsUFA, FDA is required to
Administration (FDA or Agency) is that a proposed collection of
contract with an independent
announcing an opportunity for public information has been submitted to the
accounting or consulting firm to study
comment on the interim results of a Office of Management and Budget
the workload volume and full costs
study of the workload volume and full (OMB) for review and clearance under
associated with the process for the
costs associated with the process for the the Paperwork Reduction Act of 1995.
review of biosimilar biological product
review of biosimilar biological product DATES: Fax written comments on the
applications. This notice solicits
applications (interim report). This study comments on the interim report, and the collection of information by October 26,
was conducted by an independent final report is due no later than 2015.
consulting firm, and it fulfills FDA’s September 30, 2016. The interim report ADDRESSES: To ensure that comments on
statutory requirement under the first is described in section 744I(d) of the the information collection are received,
authorization of the Biosimilar User Fee FD&C Act (21 U.S.C. 379j–53(d)) (http:// OMB recommends that written
Act of 2012 (BsUFA), which enables uscode.house.gov/ comments be faxed to the Office of
FDA to collect user fees for the review view.xhtml?req=granuleid:U.S.C.- Information and Regulatory Affairs,
of biosimilar biological applications for prelim-title21-section379j- OMB, Attn: FDA Desk Officer, FAX:
fiscal years 2013 to 2017. This notice 53&num=0&edition=prelim), as 202–395–7285, or emailed to oira_
solicits comments on the interim report. amended by the Food and Drug submission@omb.eop.gov. All
DATES: The interim report will be Administration Safety and Innovation comments should be identified with the
tkelley on DSK3SPTVN1PROD with NOTICES

released on September 24, 2015, and Act enacted in 2012. title Electronic User Fee Payment
will be available at http://www.fda.gov/ Request Forms. Also include the FDA
downloads/ForIndustry/UserFees/ II. Comments docket number found in brackets in the
BiosimilarUserFeeActBsUFA/ FDA is issuing this notice to request heading of this document.
UCM459686.pdf. Submit either public comment on the interim report. FOR FURTHER INFORMATION CONTACT: FDA
electronic or written comments on the Interested persons may submit either PRA Staff, Office of Operations, Food
interim report by October 26, 2015. electronic comments to http:// and Drug Administration, 8455

VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1

Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 57623

Dated: September 17, 2015. collection of information, to the complete information is provided for
Leslie Kux, Division of Dockets Management (HFA– FDA’s consideration and will facilitate
Associate Commissioner for Policy. 305), Food and Drug Administration, FDA’s processing and review. A copy of
[FR Doc. 2015–24228 Filed 9–23–15; 8:45 am] 5630 Fishers Lane, Rm. 1061, Rockville, the form is attached as Appendix A to
BILLING CODE 4164–01–P
MD 20852. All comments should be this guidance.
identified with the docket number On June 22, 2009, the President
found in brackets in the heading of this signed the Family Smoking Prevention
DEPARTMENT OF HEALTH AND document. and Tobacco Control Act (Pub. L. 111–
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: 31) (Tobacco Control Act) into law. The
With regard to the draft guidance: Tobacco Control Act amends the
Food and Drug Administration Laura Rich or Deirdre Jurand, Center for Federal Food, Drug, and Cosmetic Act
[Docket No. FDA–2014–D–1939] Tobacco Products, Food and Drug (the FD&C Act) and grants FDA
Administration, 10903 New Hampshire authority to regulate the manufacture,
Use of Investigational Tobacco Ave., Silver Spring, MD 20993–0002, 1– marketing, and distribution of tobacco
Products; Draft Guidance for Industry 877–287–1373, CTPRegulations@ products to protect public health
and Investigators; Availability fda.hhs.gov, laura.rich@fda.hhs.gov, or generally and to reduce tobacco use by
Deirdre.Jurand@fda.hhs.gov. minors.
AGENCY: Food and Drug Administration, With regard to the proposed collection To introduce or deliver for
HHS. of information: FDA PRA Staff, Office of introduction into interstate commerce a
ACTION: Notice. Operations, Food and Drug new tobacco product, there must be in
Administration, 8455 Colesville Rd., effect a marketing authorization order
SUMMARY: The Food and Drug issued by FDA for the tobacco product
COLE–14526, Silver Spring, MD 20993–
Administration (FDA) is announcing the under section 910(c)(1)(A)(i) of the
0002, PRAStaff@fda.hhs.gov.
availability of a draft guidance for FD&C Act (21 U.S.C. 387j(c)(1)(A)(i))
industry and investigators entitled ‘‘Use SUPPLEMENTARY INFORMATION:
unless, in brief:
of Investigational Tobacco Products.’’ I. Background • A substantial equivalence order
The draft guidance, when finalized, will under section 910(a)(2)(A)(i) of the
describe FDA’s current thinking FDA is announcing the availability of
a draft guidance for industry and FD&C Act is in effect for the tobacco
regarding the definition of product;
‘‘investigational tobacco product’’ and investigators entitled ‘‘Use of
Investigational Tobacco Products.’’ This • FDA has granted a request for an
will discuss the kind of information
draft guidance, when finalized, will exemption of the tobacco product from
FDA intends to consider in making
describe FDA’s current thinking the requirement to obtain a substantial
enforcement decisions regarding the use
regarding the definition of equivalence order and the manufacturer
of investigational tobacco products until
‘‘investigational tobacco product’’ and has made the required submission
regulations governing the use of
will discuss the kind of information under section 905(j)(1)(A)(ii) of the
investigational tobacco products become
FDA intends to consider in making FD&C Act and waited 90 days before
effective or FDA provides written notice
enforcement decisions regarding the use introducing its product to the market; or
of its intent to change its enforcement
of investigational tobacco products until • The manufacturer has submitted a
policy.
regulations governing the use of substantial equivalence report in
DATES: Although you can comment on investigational tobacco products become accordance with section 910(a)(2)(B) of
any guidance at any time (see 21 CFR effective or FDA provides written notice the FD&C Act and there is no order
10.115(g)(5)), to ensure that the Agency of its intent to change its enforcement finding that the tobacco product is not
considers your comment on this draft policy. It is intended to provide substantially equivalent.
guidance before it begins work on the guidance not only to persons who To introduce or deliver for
final version of the guidance, submit currently intend to submit study introduction into interstate commerce a
either electronic or written comments information to FDA, but to all persons modified risk tobacco product, there
on the draft by November 23, 2015. who conduct ‘‘nonclinical laboratory must be in effect an order under section
Submit either electronic or written studies,’’ as that term is used in the draft 911(g) of the FD&C Act (21 U.S.C.
comments on the proposed collection of guidance, and ‘‘clinical investigations,’’ 387k(g)) and the applicant must satisfy
information by November 23, 2015. as that term is used in the draft any applicable premarket review
ADDRESSES: Submit written requests for guidance, using investigational tobacco requirements under section 910 of the
single copies of the draft guidance to the products. FD&C Act.
Center for Tobacco Products, Food and The draft guidance also discusses that Further, a tobacco product must
Drug Administration, 10903 New for clinical investigations, a sponsor (as conform in all respects with applicable
Hampshire Ave., Silver Spring, MD defined in the guidance) may submit tobacco product standards established
20993. Send one self-addressed information regarding a proposed use of under section 907 of the FD&C Act (21
adhesive label to assist that office in an investigational tobacco product to U.S.C. 387g).
processing your request or include a fax FDA for review prior to enrolling Persons intending to file submissions
number to which the draft guidance subjects. As discussed in the guidance, with FDA to demonstrate that a tobacco
may be sent. See the SUPPLEMENTARY FDA encourages this type of voluntary product meets the criteria for marketing
INFORMATION section for electronic submission because it will allow FDA to set forth in section 910 or 911 of the
tkelley on DSK3SPTVN1PROD with NOTICES

access to the draft guidance document. work with a sponsor to help ensure that FD&C Act, and other researchers seeking
Submit electronic comments on the the factors FDA considers in making to study tobacco products, may need to
draft guidance, including comments on enforcement decisions are appropriately conduct or sponsor studies involving
the proposed collection of information, accounted for. FDA has created a form tobacco products that do not have
to http://www.regulations.gov. Submit to assist sponsors in submitting marketing authorization or that do not
written comments on the draft guidance, information. While use of the form is comply with an applicable tobacco
including comments on the proposed voluntary, it will help ensure that product standard.

VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1

Document Created: 2018-02-26 10:18:11
Document Modified: 2018-02-26 10:18:11

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		Fax written comments on the collection of information by October 26, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 57621

80 FR 57621 - 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 SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 185 (September 24, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration