80_FR_31709 80 FR 31603 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792

80 FR 31603 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 106 (June 3, 2015)

Page Range31603-31604
FR Document2015-13471

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 106 (Wednesday, June 3, 2015) 
[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Pages 31603-31604]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0194]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Biosimilars User Fee 
Cover Sheet; Form FDA 3792

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 July 6, 
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 OMB control number 0910-0718. 
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 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.

Biosimilars User Fee Cover Sheet; Form FDA 3792

OMB Control Number 0910-0718--Extension

    The Patient Protection and Affordable Care Act (Pub. L. 111-148) 
contains a subtitle called the Biologics Price Competition and 
Innovation Act of 2009 (Title VII Subtitle A) (BPCI Act) that amends 
the Public Health Service Act (42 U.S.C. 262) (PHS Act) and other 
statutes to create an abbreviated approval pathway for biological 
products shown to be biosimilar to or interchangeable with an FDA-
licensed reference biological product. Section 351(k) of the PHS Act, 
added by the BPCI Act, allows a company to submit an application for 
licensure of a biosimilar or interchangeable biological product. The 
BPCI Act also amends section 735 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the 
definition of ``human drug application'' for the purposes of the 
prescription drug user fee provisions. The BPCI Act directs FDA to 
develop recommendations for a biosimilar biological product user fee 
program for fiscal years 2013 through 2017. FDA's recommendations for a 
biosimilar biological product user fee program were submitted to 
Congress on January 13, 2012.
    FDA's biosimilar biological product user fee program requires FDA 
to assess and collect user fees for certain meetings concerning 
biosimilar biological product development (BPD meetings), 
investigational new drug applications (INDs) intended to support a 
biosimilar biological product application, and biosimilar biological 
product applications and supplements. Form FDA 3792, the Biosimilars 
User Fee Cover Sheet, requests the minimum necessary information to 
determine the amount of the fee required, and to account for and track 
user fees. The form provides a cross-reference of the fees submitted 
for a submission with the actual submission by using a unique number 
tracking system. The information collected is used by FDA's Center for 
Drug Evaluation and Research and Center for Biologics Evaluation and 
Research to initiate the administrative screening of biosimilar 
biological product INDs, applications, and supplements, and to account 
for and track user fees associated with BPD meetings.
    In the Federal Register of January 27, 2015 (80 FR 4272), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Respondents to this collection of information are manufacturers of 
biosimilar biological product candidates. Based on the number of Form 
FDA 3792s we have received, we estimate the burden of this collection 
of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     No. of
                          FDA form No.                               No. of       responses per   Total annual     Average burden  per      Total hours
                                                                   respondents     respondent       responses            response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biosimilars User Fee Cover Sheet; Form FDA 3792................              20               1              20        0.50 (30 minutes)              10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 31604]]

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13471 Filed 6-2-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices 31603 notice will be included in all information has been submitted to the and Cosmetic Act (21 U.S.C. 379g) to stakeholder discussions while FDA Office of Management and Budget include 351(k) applications in the negotiates with the regulated industry. (OMB) for review and clearance under definition of ‘‘human drug application’’ Stakeholders who decide to participate the Paperwork Reduction Act of 1995. for the purposes of the prescription drug in these monthly meetings at a later DATES: Fax written comments on the user fee provisions. The BPCI Act time may still participate in remaining collection of information by July 6, directs FDA to develop monthly meetings by notifying FDA (see 2015. recommendations for a biosimilar ADDRESSES). These stakeholder ADDRESSES: To ensure that comments on biological product user fee program for discussions will satisfy the requirement the information collection are received, fiscal years 2013 through 2017. FDA’s in section 744C(d)(3) of the FD&C Act. OMB recommends that written recommendations for a biosimilar comments be faxed to the Office of biological product user fee program II. Notification of Intent To Participate Information and Regulatory Affairs, were submitted to Congress on January in Periodic Consultation Meetings OMB, Attn: FDA Desk Officer, FAX: 13, 2012. If you intend to participate in FDA’s biosimilar biological product 202–395–7285, or emailed to oira_ continued periodic stakeholder submission@omb.eop.gov. All user fee program requires FDA to assess consultation meetings regarding GDUFA comments should be identified with the and collect user fees for certain reauthorization, please provide OMB control number 0910–0718. Also meetings concerning biosimilar notification by email to include the FDA docket number found biological product development (BPD GenericDrugPolicy@fda.hhs.gov by in brackets in the heading of this meetings), investigational new drug August 14, 2015. Your email should document. applications (INDs) intended to support contain complete contact information, a biosimilar biological product including name, title, affiliation, FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food application, and biosimilar biological address, email address, phone number, product applications and supplements. and notice of any special and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Form FDA 3792, the Biosimilars User accommodations required because of Fee Cover Sheet, requests the minimum disability. Stakeholders will receive Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. necessary information to determine the confirmation and additional information amount of the fee required, and to about the first meeting once FDA SUPPLEMENTARY INFORMATION: In account for and track user fees. The receives their notification. compliance with 44 U.S.C. 3507, FDA form provides a cross-reference of the Dated: May 29, 2015. has submitted the following proposed fees submitted for a submission with the collection of information to OMB for Leslie Kux, actual submission by using a unique review and clearance. Associate Commissioner for Policy. number tracking system. The [FR Doc. 2015–13465 Filed 6–2–15; 8:45 am] Biosimilars User Fee Cover Sheet; Form information collected is used by FDA’s BILLING CODE 4164–01–P FDA 3792 Center for Drug Evaluation and Research OMB Control Number 0910–0718— and Center for Biologics Evaluation and Extension Research to initiate the administrative DEPARTMENT OF HEALTH AND screening of biosimilar biological HUMAN SERVICES The Patient Protection and Affordable product INDs, applications, and Care Act (Pub. L. 111–148) contains a supplements, and to account for and Food and Drug Administration subtitle called the Biologics Price track user fees associated with BPD Competition and Innovation Act of 2009 meetings. [Docket No. FDA–2012–N–0194] (Title VII Subtitle A) (BPCI Act) that amends the Public Health Service Act In the Federal Register of January 27, Agency Information Collection 2015 (80 FR 4272), FDA published a 60- (42 U.S.C. 262) (PHS Act) and other Activities; Submission for Office of day notice requesting public comment statutes to create an abbreviated Management and Budget Review; on the proposed collection of approval pathway for biological Comment Request; Biosimilars User information. No comments were products shown to be biosimilar to or Fee Cover Sheet; Form FDA 3792 received. interchangeable with an FDA-licensed AGENCY: Food and Drug Administration, reference biological product. Section Respondents to this collection of HHS. 351(k) of the PHS Act, added by the information are manufacturers of ACTION: Notice. BPCI Act, allows a company to submit biosimilar biological product an application for licensure of a candidates. Based on the number of SUMMARY: The Food and Drug biosimilar or interchangeable biological Form FDA 3792s we have received, we Administration (FDA) is announcing product. The BPCI Act also amends estimate the burden of this collection of that a proposed collection of section 735 of the Federal Food, Drug, information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 No. of No. of Total annual Average burden FDA form No. responses per Total hours respondents responses per response respondent tkelley on DSK3SPTVN1PROD with NOTICES Biosimilars User Fee Cover Sheet; Form FDA 3792 .................................................................. 20 1 20 0.50 (30 minutes) 10 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 18:57 Jun 02, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\03JNN1.SGM 03JNN1

31604 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Notices Dated: May 29, 2015. addressed label to assist that office in or written comments to the Division of Leslie Kux, processing your request. See the Dockets Management (see ADDRESSES). It Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION section for is only necessary to send one set of [FR Doc. 2015–13471 Filed 6–2–15; 8:45 am] electronic access to the draft standard comments. Identify comments with the BILLING CODE 4164–01–P MOU. docket number found in brackets in the Submit electronic comments on the heading of this document. Received new draft standard MOU or on the comments may be seen in the Division DEPARTMENT OF HEALTH AND collection of information to http:// of Dockets Management between 9 a.m. HUMAN SERVICES www.regulations.gov. Submit written and 4 p.m., Monday through Friday, and comments to the Division of Dockets will be posted to the docket at http:// Food and Drug Administration Management (HFA–305), Food and Drug www.regulations.gov. [Docket No. FDA–2014–N–1459] Administration, 5630 Fishers Lane, rm. III. Electronic Access 1061, Rockville, MD 20852. Memorandum of Understanding FOR FURTHER INFORMATION CONTACT: Persons with access to the Internet Addressing Certain Distributions of Edisa Gozun, Center for Drug Evaluation may obtain the draft standard MOU at Compounded Human Drug Products and Research, Food and Drug http://www.regulations.gov. Between the States and the Food and Administration, 10903 New Hampshire Dated: May 29, 2015. Drug Administration; Extension of Ave., Bldg. 51, suite 5100, Silver Spring, Leslie Kux, Comment Period MD 20993–0002, 301–796–3110. Associate Commissioner for Policy. AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: [FR Doc. 2015–13466 Filed 6–2–15; 8:45 am] HHS. I. Background BILLING CODE 4164–01–P ACTION:Notice of availability; extension In the Federal Register of February of comment period. 19, 2015 (80 FR 8874), FDA published DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug a notice of availability of a draft HUMAN SERVICES Administration (FDA or Agency) is standard MOU entitled ‘‘Memorandum of Understanding Addressing Certain Health Resources and Services extending the comment period in the Distributions of Compounded Human Administration notice of availability that appeared in the Federal Register of February 19, Drug Products Between the State of [insert State] and the U.S. Food and Graduate Psychology Education 2015. In that notice of availability, FDA Program requested comments on a draft standard Drug Administration’’ with a 120-day memorandum of understanding (MOU) comment period to request comments AGENCY: Health Resources and Services entitled ‘‘Memorandum of on the draft standard MOU. The draft Administration, HHS. Understanding Addressing Certain standard MOU describes the ACTION: Notice of Class Deviation from Distributions of Compounded Human responsibilities of any State that chooses Competition Requirements for Graduate Drug Products Between the State of to sign the MOU in: (1) Investigating Psychology Education Program from [insert State] and the U.S. Food and and responding to complaints related to Open to Limited Competition. Drug Administration.’’ The draft compounded human drug products standard MOU describes the distributed outside the State and (2) SUMMARY: The Health Resources and responsibilities of any State that chooses addressing the interstate distribution of Services Administration (HRSA) is to sign the MOU in investigating and inordinate amounts of compounded issuing a limited competition for awards responding to complaints related to human drug products. Comments were among the 40 current Graduate compounded human drug products also requested on information collection Psychology Education (GPE) Program distributed outside the State and in issues under the PRA. The notice of grantees whose project periods end June addressing the interstate distribution of availability also announced the 30, 2016. No more than $1,000,000 will inordinate amounts of compounded withdrawal, effective February 19, 2015, be made available in federal fiscal year human drug products. The Agency is of an earlier draft standard MOU (FY) 2015 in the form of 1-year project taking this action to allow interested entitled ‘‘Memorandum of period grants. These awards are persons additional time to submit Understanding on Interstate Distribution specifically for interprofessional comments. of Compounded Drug Products’’ that training of doctoral psychology graduate published on January 21, 1999 (64 FR students and interns to address the DATES: FDA is extending the comment 3301). The January 1999 draft standard psychological needs of military period in the notice of availability MOU is superseded by the February personnel, veterans, and their families published on February 19, 2015 (80 FR 2015 draft standard MOU. in civilian and community-based 8874) which includes comment on The Agency is extending the comment settings, including those in rural areas. information collection issues under the period both for the draft standard MOU An estimated five grants will be Paperwork Reduction Act of 1995 (the and for information collection issues awarded with a ceiling amount of PRA). Submit either electronic or under the PRA for 30 days, until July 20, $190,000 per grant for 1 year. These written comments on the draft standard 2015. The Agency believes that a 30-day funds will be used to establish, expand, MOU or on information collection extension allows adequate time for and/or enhance activities that were issues under the PRA by July 20, 2015. interested persons to submit comments funded under the FY 2013 GPE tkelley on DSK3SPTVN1PROD with NOTICES ADDRESSES: Submit written requests for without significantly delaying Program. single copies of the MOU to Edisa resolution of these important issues. Program funds are to be used for Gozun, Center for Drug Evaluation and stipend support for interns and doctoral Research, Food and Drug II. Request for Comments students, faculty development, Administration, 10903 New Hampshire Interested persons may submit either curriculum and instructional design, Ave., Bldg. 51, suite 5100, Silver Spring, electronic comments regarding this program content enhancement, program MD 20993–0002. Send one self- document to http://www.regulations.gov infrastructure development, and the VerDate Sep<11>2014 18:57 Jun 02, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\03JNN1.SGM 03JNN1


Document Created: 2015-12-15 15:09:02
Document Modified: 2015-12-15 15:09:02
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 July 6, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 31603 
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