80 FR 31388 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Generic Drug User Fee Cover Sheet; Form FDA 3794

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 105 (June 2, 2015)

Page Range		31388-31389
FR Document		2015-13352

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments concerning collection of information using Form FDA 3794 entitled ``Generic Drug User Fee Cover Sheet.''

Federal Register, Volume 80 Issue 105 (Tuesday, June 2, 2015)

[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31388-31389]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0748]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on Generic Drug User Fee Cover 
Sheet; Form FDA 3794

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments concerning collection of 
information using Form FDA 3794 entitled ``Generic Drug User Fee Cover 
Sheet.''

DATES: Submit either electronic or written comments on the collection 
of information by August 3, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA, (44 U.S.C. 3501-3520), 
Federal Agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is 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 (44 
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information, including each proposed extension of an existing 
collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Generic Drug User Fee Cover Sheet; Form FDA 3794

OMB Control Number 0910-0727--Extension

    On July 9, 2012, the Generic Drug User Fee Act (GDUFA) (Pub. L. 
112-144, Title 111) was signed into law by the President. GDUFA, 
designed to speed the delivery of safe and effective generic drugs to 
the public and reduce costs to industry, requires that generic drug 
manufacturers pay user fees to finance critical and measurable program 
enhancements. The user fees required

[[Page 31389]]

by GDUFA are as follows: A one-time fee for original abbreviated new 
drug applications (ANDAs) pending on October 1, 2012 (also known as 
backlog applications); fees for type II active pharmaceutical 
ingredient (API) and final dosage form (FDF) facilities; fees for new 
ANDAs and prior approval supplements (PASs); and a one-time fee for 
drug master files (DMFs).
    The purpose of this notice is to solicit feedback on the collection 
of information in an electronic form used to calculate and pay generic 
drug user fees. Proposed Form FDA 3794, the Generic Drug User Fee Cover 
Sheet, requests the minimum necessary information to determine if a 
person has satisfied all relevant user fee obligations. The proposed 
form is modeled on other FDA user fee cover sheets, including Form FDA 
3397, the Prescription Drug User Fee Act Cover Sheet. The information 
collected would be used by FDA to initiate the administrative screening 
of generic drug submissions and DMFs, support the inspection of generic 
drug facilities, and otherwise support the generic drug program. A copy 
of the proposed form will be available in the docket for this notice.
    Respondents to this proposed collection of information would be 
potential or actual generic application holders and/or related 
manufacturers (manufacturers of FDF and/or APIs). Companies with 
multiple applications will submit a cover sheet for each application 
and facility. Based on FDA's database of application holders and 
related manufacturers, we estimate that approximately 460 companies 
would submit a total of 3,544 cover sheets annually to pay for 
application and facility user fees. FDA estimates that the 3,544 annual 
cover sheet responses would break down as follows: 1,439 facilities 
fees, 942 ANDAs, 502 PASs, and 661 Type II API DMFs. The estimated 
hours per response are based on FDA's past experience with other 
submissions and range from approximately 0.1 to 0.5 hours. The hours 
per response are estimated at the upper end of the range to be 
conservative.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              FDA form                                  Number of      responses  per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3794...........................................................             460              7.7            3,544    0.5 (30 min.)            1,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13352 Filed 6-1-15; 8:45 am]
 BILLING CODE 4164-01-P

31388 Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices

the Agency under the Federal Food, respondent submits requests for formal accordance with this guidance,
Drug, and Cosmetic Act or section 351 dispute resolution to CBER annually. including the time it takes to gather and
of the Public Health Service Act who The total annual responses are the total copy brief statements describing the
requests formal resolution of a scientific number of requests submitted to CDER issue from the perspective of the person
or procedural dispute. and CBER in 1 year, including requests with the dispute, brief statements
Burden Estimate: Provided in this for dispute resolution that a single describing the history of the matter, and
document is an estimate of the annual respondent submits more than one time. supporting information that has already
reporting burden for requests for dispute FDA estimates that CDER receives been submitted to the Agency. Based on
resolution. Based on data collected from approximately 31 requests annually and experience, FDA estimates that
review divisions and offices within CBER receives approximately 1 request approximately 8 hours on average
CDER and CBER, FDA estimates that annually. The hours per response is the would be needed per response.
approximately eight sponsors and estimated number of hours that a Therefore, FDA estimates that 8 hours
applicants (respondents) submit respondent would spend preparing the will be spent per year by respondents
requests for formal dispute resolution to information to be submitted with a requesting formal dispute resolution
CDER annually and approximately one request for formal dispute resolution in under the guidance.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Requests for formal dispute resolution responses per burden per Total hours
respondents responses
respondent response

CDER ................................................................................... 8 2 31 8 248
CBER ................................................................................... 1 1 1 8 8

Total .............................................................................. ........................ ........................ ........................ ........................ 256
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: May 27, 2015. DATES: Submit either electronic or before submitting the collection to OMB
Leslie Kux, written comments on the collection of for approval. To comply with this
Associate Commissioner for Policy. information by August 3, 2015. requirement, FDA is publishing notice
[FR Doc. 2015–13386 Filed 6–1–15; 8:45 am] ADDRESSES: Submit electronic of the proposed collection of
BILLING CODE 4164–01–P comments on the collection of information set forth in this document.
information to http:// With respect to the following
www.regulations.gov. Submit written collection of information, FDA invites
DEPARTMENT OF HEALTH AND comments on the collection of comments on these topics: (1) Whether
HUMAN SERVICES information to the Division of Dockets the proposed collection of information
Management (HFA–305), Food and Drug is necessary for the proper performance
Food and Drug Administration Administration, 5630 Fishers Lane, Rm. of FDA’s functions, including whether
1061, Rockville, MD 20852. All the information will have practical
[Docket No. FDA–2012–N–0748] comments should be identified with the utility; (2) the accuracy of FDA’s
docket number found in brackets in the estimate of the burden of the proposed
Agency Information Collection heading of this document. collection of information, including the
Activities; Proposed Collection; FOR FURTHER INFORMATION CONTACT: FDA validity of the methodology and
Comment Request; Guidance for PRA Staff, Office of Operations, Food assumptions used; (3) ways to enhance
Industry on Generic Drug User Fee and Drug Administration, 8455 the quality, utility, and clarity of the
Cover Sheet; Form FDA 3794 Colesville Rd., COLE–14526, Silver information to be collected; and (4)
AGENCY: Food and Drug Administration, Spring, MD 20993–0002, PRAStaff@ ways to minimize the burden of the
HHS. fda.hhs.gov. collection of information on
SUPPLEMENTARY INFORMATION: Under the
respondents, including through the use
ACTION: Notice. of automated collection techniques,
PRA, (44 U.S.C. 3501–3520), Federal
SUMMARY: The Food and Drug Agencies must obtain approval from the when appropriate, and other forms of
Administration (FDA) is announcing an Office of Management and Budget information technology.
opportunity for public comment on the (OMB) for each collection of Generic Drug User Fee Cover Sheet;
proposed collection of certain information they conduct or sponsor. Form FDA 3794
information by the Agency. Under the ‘‘Collection of information’’ is defined
Paperwork Reduction Act of 1995 (the in 44 U.S.C. 3502(3) and 5 CFR OMB Control Number 0910–0727—
PRA), Federal Agencies are required to 1320.3(c) and includes Agency requests Extension
publish notice in the Federal Register or requirements that members of the On July 9, 2012, the Generic Drug
concerning each proposed collection of public submit reports, keep records, or User Fee Act (GDUFA) (Pub. L. 112–
asabaliauskas on DSK5VPTVN1PROD with NOTICES

information, including each proposed provide information to a third party. 144, Title 111) was signed into law by
extension of an existing collection of Section 3506(c)(2)(A) of the PRA (44 the President. GDUFA, designed to
information, and to allow 60 days for U.S.C. 3506(c)(2)(A)) requires Federal speed the delivery of safe and effective
public comment in response to the Agencies to provide a 60-day notice in generic drugs to the public and reduce
notice. This notice solicits comments the Federal Register concerning each costs to industry, requires that generic
concerning collection of information proposed collection of information, drug manufacturers pay user fees to
using Form FDA 3794 entitled ‘‘Generic including each proposed extension of an finance critical and measurable program
Drug User Fee Cover Sheet.’’ existing collection of information, enhancements. The user fees required

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Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices 31389

by GDUFA are as follows: A one-time modeled on other FDA user fee cover database of application holders and
fee for original abbreviated new drug sheets, including Form FDA 3397, the related manufacturers, we estimate that
applications (ANDAs) pending on Prescription Drug User Fee Act Cover approximately 460 companies would
October 1, 2012 (also known as backlog Sheet. The information collected would submit a total of 3,544 cover sheets
applications); fees for type II active be used by FDA to initiate the annually to pay for application and
pharmaceutical ingredient (API) and administrative screening of generic drug facility user fees. FDA estimates that the
final dosage form (FDF) facilities; fees submissions and DMFs, support the 3,544 annual cover sheet responses
for new ANDAs and prior approval inspection of generic drug facilities, and would break down as follows: 1,439
supplements (PASs); and a one-time fee otherwise support the generic drug facilities fees, 942 ANDAs, 502 PASs,
for drug master files (DMFs). program. A copy of the proposed form and 661 Type II API DMFs. The
The purpose of this notice is to solicit will be available in the docket for this estimated hours per response are based
feedback on the collection of notice. on FDA’s past experience with other
information in an electronic form used Respondents to this proposed
submissions and range from
to calculate and pay generic drug user collection of information would be
fees. Proposed Form FDA 3794, the potential or actual generic application approximately 0.1 to 0.5 hours. The
Generic Drug User Fee Cover Sheet, holders and/or related manufacturers hours per response are estimated at the
requests the minimum necessary (manufacturers of FDF and/or APIs). upper end of the range to be
information to determine if a person has Companies with multiple applications conservative.
satisfied all relevant user fee will submit a cover sheet for each FDA estimates the burden of this
obligations. The proposed form is application and facility. Based on FDA’s collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
FDA form burden per Total hours
respondents per responses response
respondent

FDA 3794 ............................................................................. 460 7.7 3,544 0.5 (30 min.) 1,772
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: May 27, 2015. Innovation and Opportunity Act of Organization, Functions, and
Leslie Kux, (WIOA), furthers these objectives by Delegations of Authority of the
Associate Commissioner for Policy. transferring three groups of programs— Department of Health and Human
[FR Doc. 2015–13352 Filed 6–1–15; 8:45 am] the Independent Living (IL) Programs, Services (HHS), Administration for
BILLING CODE 4164–01–P
the National Institute on Disability and Community Living, as last amended at
Rehabilitation Research (now titled the 79 FR 62142–62152, dated October 16,
National Institute on Disability, 2014, as follows:
DEPARTMENT OF HEALTH AND Independent Living, and Rehabilitation I. Delete Part B, ‘‘The Administration
HUMAN SERVICES Research), and the Assistive Technology for Community Living’’; in its entirety
(AT) Act programs—from the and replace with the following:
Statement of Organization, Functions, Department of Education’s Office of B.00 Mission
and Delegations of Authority; Special Education and Rehabilitative B.10 Organization
Administration for Community Living Services (OSERS) to the HHS B.20 Functions
Administration for Community Living B.00 Mission. The Administration
AGENCY: Department of Health and
(ACL). This reorganization incorporates for Community Living’s (ACL) mission
Human Services.
these programs into ACL’s structure is to maximize the independence, well-
ACTION: Notice. with the IL programs and the AT Act being, and health of older adults, people
SUMMARY: The Administration for section 5 programs included under the with disabilities across the lifespan, and
Community Living (ACL) was created in newly established Administration on their families and caregivers. ACL
order to achieve several important Disabilities; the National Institute on provides national leadership and
objectives: to reduce the fragmentation Disability, Independent Living, and direction to plan, manage, develop, and
that currently exists in federal programs Rehabilitation Research (NIDILRR) raise awareness of comprehensive and
addressing the community living service reporting directly to the ACL coordinated systems of long-term
and support needs of both the aging and Administrator; and the AT Act section services and supports that enable older
disability populations; to enhance 4 programs located in the Office of Americans and individuals with
access to quality health care and long- Consumer Access and Self- disabilities, including intellectual,
term services and supports for older Determination within the renamed developmental, physical, and other
adults and people with disabilities; to Center for Integrated Programs (formally disabilities, to maintain their health and
promote consistency in community the Center for Consumer Access and independence in their homes and
asabaliauskas on DSK5VPTVN1PROD with NOTICES

living policy across other areas of the Self-Determination). communities. ACL programs support
federal government; and to complement FOR FURTHER INFORMATION CONTACT: strong state, tribal, and local community
the community infrastructure, as Christine Phillips, Administration for networks designed to respond to the
supported by both Medicaid and other Community Living, 1 Massachusetts needs of persons with disabilities, older
federal programs, in order to better Avenue NW., Washington, DC 20201, Americans, and their families through
respond to the full spectrum of needs of 202–357–3547. advocacy, research, systems change and
seniors and persons with disabilities. SUPPLEMENTARY INFORMATION: This capacity building to ensure access to
Public Law 113–128, the Workforce notice amends part B of the Statement needed community services,

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Document Created: 2015-12-15 15:11:56
Document Modified: 2015-12-15 15:11:56

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		Submit either electronic or written comments on the collection of information by August 3, 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 31388

80 FR 31388 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Generic Drug User Fee Cover Sheet; Form FDA 3794

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 105 (June 2, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration