Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Cover Sheet; Form FDA 3397, 64523-64524 [2012-25898]
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Federal Register / Vol. 77, No. 204 / Monday, October 22, 2012 / Notices
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participants should either:
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D Patient Usefulness—Does it address
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Additional Information:
wreier-aviles on DSK5TPTVN1PROD with
Authority: 15 U.S.C. 3719.
Dated: October 15, 2012.
Farzad Mostashari,
National Coordinator for Health Information
Technology.
[FR Doc. 2012–25954 Filed 10–19–12; 8:45 am]
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Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0471]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
User Fee Cover Sheet; Form FDA 3397
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
21, 2012.
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 0910–0297. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@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.
SUMMARY:
Prescription Drug User Fee Cover
Sheet; Form FDA 3397—(OMB Control
Number 0910–0297)—Extension
Under the prescription drug user fee
provisions of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act)
(sections 735 and 736 (21 U.S.C. 379g
and 379h)), as amended, FDA has the
authority to assess and collect user fees
for certain drug and biologics license
applications and supplements to those
applications. Under this authority,
pharmaceutical companies pay a fee for
certain new drug applications (NDAs),
biologics license applications (BLAs), or
supplements submitted to the Agency
PO 00000
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64523
for review. Because the submission of
user fees concurrently with applications
and supplements is required, review of
an application by FDA cannot begin
until the fee is submitted. The
Prescription Drug User Fee Cover Sheet,
Form FDA 3397, is designed to provide
the minimum necessary information to
determine whether a fee is required for
review of an application, to determine
the amount of the fee required, and to
account for and track user fees. The
form provides a cross-reference of the
fee submitted for an application by
using a unique number tracking system.
The information collected is used by
FDA’s Center for Drug Evaluation and
Research (CDER) and Center for
Biologics Evaluation and Research
(CBER) to initiate the administrative
screening of NDAs, BLAs, and/or
supplemental applications to those
applications.
Respondents to this collection of
information are new drug and biologics
manufacturers. Based on FDA’s database
system for fiscal year (FY) 2011, there
are an estimated 260 manufacturers of
products subject to the Prescription
Drug User Fee Act (Pub. L. 105–115).
The total number of annual responses is
based on the number of submissions
received by FDA in FY 2011. CDER
received 3,363 annual responses that
include the following submissions: 114
NDAs; 4 BLAs; 1,900 manufacturing
supplements; 1,209 labeling
supplements; and 136 efficacy
supplements. CBER received 768 annual
responses that include the following
submissions: 6 BLAs; 698
manufacturing supplements; 44 labeling
supplements; and 20 efficacy
supplements. The estimated hours per
response are based on past FDA
experience with the various
submissions.
FDA is revising Form FDA 3397 in the
following ways: (1) By updating the
applicable Web sites; (2) by adding a
Privacy Act Notice pursuant to the
Privacy Act of 1974, 5 U.S.C. 552a(3)j;
(3) by adding 351(k) applications to the
CDER and CBER lists of applications
and supplements for which Form FDA
3397 need not be submitted; (4) by
adding ‘‘or proper name’’ to instruction
number 3; and (5) by making minor
editorial changes.
In the Federal Register of May 18,
2012 (77 FR 29663), 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:
E:\FR\FM\22OCN1.SGM
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Federal Register / Vol. 77, No. 204 / Monday, October 22, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Form FDA 3397 ......................................................................
260
15.89
4,131
0.5 (30 min.)
2,065.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–25898 Filed 10–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
wreier-aviles on DSK5TPTVN1PROD with
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Arthritis
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 20, 2012, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg, 31, rm 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
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modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 22151,
rintatolimod injection (proposed trade
name AMPLIGEN), submitted by
Hemispherx Biopharma, Inc., for the
treatment of patients with chronic
fatigue syndrome.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before December 6, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2:30 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 28, 2012. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
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open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 29, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Yvette
Waples at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 16, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–25878 Filed 10–19–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Infant
Mortality; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Committee on Infant
Mortality (ACIM).
Dates and Times: November 14, 2012, 8:30
a.m.–5:30 p.m.; November 15, 2012, 8:30
a.m.–3:30 p.m.
E:\FR\FM\22OCN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64523-64524]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25898]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0471]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
User Fee Cover Sheet; Form FDA 3397
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
November 21, 2012.
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 0910-0297.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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.
Prescription Drug User Fee Cover Sheet; Form FDA 3397--(OMB Control
Number 0910-0297)--Extension
Under the prescription drug user fee provisions of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21
U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and
collect user fees for certain drug and biologics license applications
and supplements to those applications. Under this authority,
pharmaceutical companies pay a fee for certain new drug applications
(NDAs), biologics license applications (BLAs), or supplements submitted
to the Agency for review. Because the submission of user fees
concurrently with applications and supplements is required, review of
an application by FDA cannot begin until the fee is submitted. The
Prescription Drug User Fee Cover Sheet, Form FDA 3397, is designed to
provide the minimum necessary information to determine whether a fee is
required for review of an application, to determine the amount of the
fee required, and to account for and track user fees. The form provides
a cross-reference of the fee submitted for an application by using a
unique number tracking system. The information collected is used by
FDA's Center for Drug Evaluation and Research (CDER) and Center for
Biologics Evaluation and Research (CBER) to initiate the administrative
screening of NDAs, BLAs, and/or supplemental applications to those
applications.
Respondents to this collection of information are new drug and
biologics manufacturers. Based on FDA's database system for fiscal year
(FY) 2011, there are an estimated 260 manufacturers of products subject
to the Prescription Drug User Fee Act (Pub. L. 105-115). The total
number of annual responses is based on the number of submissions
received by FDA in FY 2011. CDER received 3,363 annual responses that
include the following submissions: 114 NDAs; 4 BLAs; 1,900
manufacturing supplements; 1,209 labeling supplements; and 136 efficacy
supplements. CBER received 768 annual responses that include the
following submissions: 6 BLAs; 698 manufacturing supplements; 44
labeling supplements; and 20 efficacy supplements. The estimated hours
per response are based on past FDA experience with the various
submissions.
FDA is revising Form FDA 3397 in the following ways: (1) By
updating the applicable Web sites; (2) by adding a Privacy Act Notice
pursuant to the Privacy Act of 1974, 5 U.S.C. 552a(3)j; (3) by adding
351(k) applications to the CDER and CBER lists of applications and
supplements for which Form FDA 3397 need not be submitted; (4) by
adding ``or proper name'' to instruction number 3; and (5) by making
minor editorial changes.
In the Federal Register of May 18, 2012 (77 FR 29663), 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:
[[Page 64524]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3397.................................. 260 15.89 4,131 0.5 (30 min.) 2,065.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-25898 Filed 10-19-12; 8:45 am]
BILLING CODE 4160-01-P
