Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet; Form FDA 3794, 43844-43846 [2012-18232]
Download as PDF
<![CDATA[
43844
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
regard to clinical investigators,
including protocol agreements and
investigator resumes or curriculum
vitae. FDA estimates than an average of
15 minutes will be required for each
recordkeeper to add this record to the
clinical investigators’ file.
Under § 54.4(b), clinical investigators
supply to the sponsor of a covered study
financial information sufficient to allow
the sponsor to submit complete and
accurate certification or disclosure
statements. Clinical investigators are
accustomed to supplying such
information when applying for research
grants. Also, most people know the
financial holdings of their immediate
family and records of such interests are
generally accessible because they are
needed for preparing tax records. For
these reasons, FDA estimates that it will
take clinical investigators 15 minutes to
submit such records to the sponsor.
Subsequent to publication of the
60-day notice, FDA reestimated the
information collection. Upon additional
inspection of the data, FDA has updated
the estimated recordkeeping burden
hours to more accurately reflect the
burden.
In the Federal Register of March 28,
2012 (77 FR 18826), 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
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Certification—54.4(a)(1) and (a)(2)—Form FDA 3454 ........
Disclosure—54.4(a)(3)—Form FDA 3455 ...........................
Total ..............................................................................
902
90
........................
1
1
........................
902
90
........................
1
5
........................
1 There
Total hours
902
450
1,352
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping—54.6 ..........................................................
902
1
902
0.25
226
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
21 CFR Section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Clinical Investigators—54.4(b) .............................................
10,554
1
10,554
0.17
1,794
Dated: July 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed 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.’’
[FR Doc. 2012–18235 Filed 7–25–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Drug User
Fee Cover Sheet; Form FDA 3794
TKELLEY on DSK3SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
VerDate Mar<15>2010
16:42 Jul 25, 2012
Jkt 226001
Submit either electronic or
written comments on the collection of
information by September 24, 2012.
DATES:
[Docket No. FDA–2012–N–0748]
Submit electronic
comments on the collection of
information to https://
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.
ADDRESSES:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–7651,
juanmanuel.vilela@fda.hhs.gov.
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 before submitting the
collection to OMB for approval. To
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26JYN1.SGM
26JYN1
43845
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
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—New)
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
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 the 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
500 companies would submit a total of
3,850 coversheets annually to pay for
application and facility user fees. FDA
estimates that the 3,850 annual cover
sheet responses would break down as
follows: 1 2,000 facilities fees, 750
ANDAs, 750 PASs, and 350 Type II API
DMFs. We also estimate that the onetime backlog fee would affect 350
application owners sponsoring 2,700
applications. 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
Form
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
FDA 3794 2 ...........................................................................
500
7.7
3,850
0.5
1,925
1 There
2 For
are no capital costs or operating and maintenance costs associated with this collection of information.
all applicable applications and fees except for the backlog fee.
The backlog fee is a one-time fee. The
Agency expects the majority of these
fees to be received in the first year only.
The estimated reporting burden for the
backlog fee is shown in table 2 of this
document.
TABLE 2—ESTIMATED ONE-TIME ANNUAL REPORTING BURDEN 1
Form
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden
per
response
Total hours
FDA 3794 2 ...........................................................................
350
7.7
2,700
0.5
1,350
1 Ther
TKELLEY on DSK3SPTVN1PROD with NOTICES
2 For
are no capital costs or operating maintenance costs associated with this collection of information.
backlog fee.
1 These estimates are based on conversations
between the Agency and representatives of
VerDate Mar<15>2010
18:06 Jul 25, 2012
Jkt 226001
regulated industry during the generic drug user fee
negotiations.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
E:\FR\FM\26JYN1.SGM
26JYN1
43846
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18232 Filed 7–25–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Food and Drug Administration
Pediatric Medical Devices Workshop;
Notice of Workshop
AGENCY:
Food and Drug Administration,
HHS.
TKELLEY on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug Administration’s
(FDA) Office of Orphan Products
Development is announcing the
following workshop: FDA Pediatric
Medical Devices Workshop. This
meeting is intended to focus on
challenges in pediatric device
development—namely, business
planning and funding concerns; and
how sponsors can most effectively
interact with the FDA. The goal of this
meeting is to engage and educate
pediatric innovators and device
industry sponsors.
This educational meeting will consist
of live presentations provided by FDA
experts from various Centers and
Offices, as well as from outside experts.
The interactive meeting will also
include a ‘‘mock’’ FDA pre-submission
meeting for a ‘‘mock’’ pediatric medical
device, to illustrate how such
encounters may transpire. In addition,
attendees will have an opportunity
during lunch to engage with Pediatric
Device Consortia Grant Program leaders.
The meeting will be recorded for
subsequent posting on the FDA Web
site.
Date and Time: The meeting will be
held on September 24, 2012, from 8 a.m.
to 5:30 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
For participants who cannot attend the
live meeting, a recorded Web cast will
be made available after the meeting.
Contact: Linda Ulrich, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm.5206, Silver Spring,
MD 20993–0002, 301–796–8686, FAX:
301–847–8621, email:
megan.mcnamee@icfi.com.
Registration: Interested participants
may register for this meeting at the
following Web site: https://events-
VerDate Mar<15>2010
16:42 Jul 25, 2012
Jkt 226001
support.com/events/FDA_OOPD_
Pediatric_Medical_Devices_Workshop.
Please note that registration for the live
meeting will be limited based on
available seating.
If you need sign language
interpretation during this meeting,
please contact Linda Ulrich at:
Linda.Ulrich@fda.hhs.gov by August 24,
2012.
The FDA Pediatric Medical Devices
Workshop is supported by FDA’s Office
of Orphan Product Development and
will include participants from the FDA’s
Center for Devices and Radiologic
Health.
(FDA has verified the Web site
addresses throughout this document,
but we are not responsible for any
subsequent changes to the Web sites
after this document publishes in the
Federal Register.)
Dated: July 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18231 Filed 7–25–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Draft Policy on Conferring With Urban
Indian Organizations
Indian Health Service,
Department of Health and Human
Services.
ACTION: Notice, with a 45-day comment
period.
AGENCY:
This Notice sets forth the
Indian Health Service policy for
conferring with urban Indian
organizations and invites comments
within 45 days. In March 2010, the
Indian Health Care Improvement Act
was reauthorized and amended as part
of the Patient Protection and Affordable
Care Act, Public Law 111–148, as
amended by the Health Care and
Education Reconciliation Act (together,
the Affordable Care Act), Public Law
111–152. One of the changes made to
the IHCIA was to create a new
requirement that the IHS ‘‘confer’’ with
UIOs, to the maximum extent
practicable, in carrying out the Act as
defined by the Indian Health Care
Improvement Reauthorization and
Extension Act, as enacted and amended
by the Affordable Care Act.
DATES: We will consider all comments
received by September 10, 2012.
ADDRESSES: Submit comments by email
to Betty.Gould@ihs.gov; or by US mail
to: Ms. Betty Gould, Regulations Officer,
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Indian Health Service, 801 Thompson
Avenue, TMP Suite 450, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT: Ms.
Phyllis Wolfe, Director, Office of Urban
Indian Health Programs, Indian Health
Service, 801 Thompson Avenue, Suite
200, Rockville, Maryland 20852.
Telephone 301/443–4680 (This is not a
toll free number).
Policy on Conferring With Urban
Indian Organizations
5–26.1 Introduction
A. Purpose. Congress has specifically
declared that it is the policy of the
Nation ‘‘to ensure the highest possible
health status for Indians and urban
Indians.’’ 25 U.S.C. 1602(1). The U. S.
Department of Health and Human
Services (HHS) is committed to working
with Indian and urban Indian
communities to meet this policy. This
policy applies to the Indian Health
Service (IHS).
This Notice establishes the IHS policy
and procedures for conferring with
urban Indian organizations (UIOs). The
IHS will use this conferring policy to
ensure that the health care needs of the
urban Indian population are considered
at the local, Area, and national levels,
when implementing and carrying out
the Indian Health Care Improvement
Act (IHCIA).
B. Background. Urban Indian
organizations are a major provider of
health care to urban American Indians
and Alaska Natives (AI/AN) across the
country. When the IHCIA was enacted
into law in 1976, it identified the
authorities, responsibilities, and
functions of the IHS, the primary
Federal Agency charged with providing
health care to AI/AN. The IHCIA
included the authority for the IHS to
‘‘establish programs in urban centers to
make health services more accessible to
urban Indians’’ [Indian Health Care
Improvement Act, Title V, section 501,
Pub. L. 94–437, 90 Statute (Stat.) 1400,
1410 (1976), codified at 25 United States
Code (U.S.C.) 1651]. The IHS carries out
this authority through contracts with
and grants to UIOs. In March 2010, as
part of the Affordable Care Act,
Congress reauthorized and amended the
IHCIA. The reauthorization of the IHCIA
included a requirement that the IHS
‘‘confer,’’ to the maximum extent
practicable, with UIOs in carrying out
the IHCIA.
C. Policy. It is IHS policy to confer
with UIOs, to the maximum extent
practicable, whenever a ‘‘critical event
or issue,’’ as defined in this Notice,
arises in implementing or carrying out
the IHCIA.
E:\FR\FM\26JYN1.SGM
26JYN1
]]>Agencies
[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43844-43846]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18232]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0748]
Agency Information Collection Activities; Proposed Collection;
Comment Request; 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 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 September 24, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to https://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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
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 before
submitting the collection to OMB for approval. To
[[Page 43845]]
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--New)
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 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 the 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 500 companies would submit a
total of 3,850 coversheets annually to pay for application and facility
user fees. FDA estimates that the 3,850 annual cover sheet responses
would break down as follows: \1\ 2,000 facilities fees, 750 ANDAs, 750
PASs, and 350 Type II API DMFs. We also estimate that the one-time
backlog fee would affect 350 application owners sponsoring 2,700
applications. 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.
---------------------------------------------------------------------------
\1\ These estimates are based on conversations between the
Agency and representatives of regulated industry during the generic
drug user fee negotiations.
---------------------------------------------------------------------------
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3794 \2\....................................................... 500 7.7 3,850 0.5 1,925
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ For all applicable applications and fees except for the backlog fee.
The backlog fee is a one-time fee. The Agency expects the majority
of these fees to be received in the first year only. The estimated
reporting burden for the backlog fee is shown in table 2 of this
document.
Table 2--Estimated One-Time Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3794 \2\....................................................... 350 7.7 2,700 0.5 1,350
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Ther are no capital costs or operating maintenance costs associated with this collection of information.
\2\ For backlog fee.
[[Page 43846]]
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18232 Filed 7-25-12; 8:45 am]
BILLING CODE 4160-01-P
