Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Fast Track Drug Development Programs-Designation, Development, and Application Review, 33177-33179 [05-11206]
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Federal Register / Vol. 70, No. 108 / Tuesday, June 7, 2005 / Notices
Application Consideration: The
Commissioner’s funding decision is
based on an analysis of the application
by the review panel, panel review scores
and recommendations; an analysis by
ANA staff; review of previous ANA
grantee’s past performance; comments
from State and Federal agencies having
contract and grant performance related
information; and other interested
parties. The Commissioner makes grant
awards consistent with the purpose of
the Native American Programs Act
(NAPA), all relevant statutory and
regulatory requirements, this program
announcement, and the availability of
appropriated funds. The Commissioner
reserves the right to award more, or less,
than the funds described or under such
circumstances as may be deemed to be
in the best interest of the Federal
government. Applicants may be
required to reduce the scope of projects
based on the amount of approved
award.
Federal. Since ACF will be using nonFederal reviewers in the process,
applicants have the option of omitting
from the application copies (not the
original) of specific salary rates or
amounts for individuals specified in the
application budget and Social Security
numbers, if otherwise required for
individuals. The copies may include
summary salary information.
Approved but Unfunded
Applications. Applications that are
approved but unfunded may be held
over for funding in the next funding
cycle, pending the availability of funds,
for a period not to exceed one year.
3. Anticipated Announcement and
Award Dates
Approximately 120 days after the
application due date, the successful
applicants will be notified by mail
through the issuance of a Financial
Assistance Award document which will
set forth the amount of funds granted,
the terms and conditions of the grant,
the effective date of the grant, the
budget period for which initial support
will be given, the non-Federal share to
be provided and the total project period
for which support is contemplated. The
Financial Assistance Award will be
signed by the Grants Officer and sent to
the applicant’s Authorizing Official.
Applications not funded in this
competition will be notified in writing.
VI. Award Administration Information
The successful applicants will be
notified through the issuance of a
Financial Assistance Award document
which sets forth the amount of funds
20:54 Jun 06, 2005
2. Administrative and National Policy
Requirements
Grantees are subject to the
requirements in 45 CFR Part 74 (nongovernmental) or 45 CFR part 92
(governmental); 45 CFR part 1336; and,
Native American Programs Act of 1974–
42 U.S.C. 2991 et seq.
Direct Federal grants, subaward
funds, or contracts under this Program
shall not be used to support inherently
religious activities such as religious
instruction, worship, or proselytization.
Therefore, organizations must take steps
to separate, in time or location, their
inherently religious activities from the
services funded under this Program.
Regulations pertaining to the
prohibition of Federal funds for
inherently religious activities can be
found on the HHS Web site at: https://
www.os.dhhs.gov/fbci/waisgate21.pdf.
3. Reporting Requirements
Program Progress Reports: Quarterly
Financial Reports: Quarterly
Special Reporting Requirements: An
original and one copy of each
performance report and financial status
report must be submitted to the Grants
Officer. Failure to submit these reports
when required will mean the grantee is
non-compliant with the terms and
conditions of the grant award and
subject to administrative action or
termination. Program progress reports
are submitted 30 days after each quarter
(3-month intervals) of the budget period.
The final program progress report, due
90 days after the project period end
date, shall cover grantee performance
during the entire project period. All
grantees shall use the SF 269 (Long
Form) to report the status of funds.
Financial Status Reports are submitted
30 days after each quarter (3-month
intervals) of the budget period. The final
SF 269 report shall be due 90 days after
the end of the project period.
VII. Agency Contacts
1. Award Notices
VerDate jul<14>2003
granted, the terms and conditions of the
grant, the effective date of the grant, the
budget period for which initial support
will be given, the non-Federal share to
be provided (if applicable), and the total
project period for which support is
contemplated. The Financial Assistance
Award will be signed by the Grants
Officer and transmitted via postal mail.
Organizations whose applications will
not be funded will be notified in
writing.
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ANA Applicant Help Desk, Aerospace
Center, 8th Floor West, 370 L’Enfant
Promenade SW., Washington, DC 20047,
PO 00000
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Phone: 877–922–9262, E-mail:
ana@acf.hhs.gov.
Grants Management Office Contact
Tim Chappelle, Administration for
Children and Families, Office of Grants
Management, Division of Discretionary
Grants, 370 L’Enfant Promenade SW.,
Aerospace Building 8th Floor West,
Washington, DC 20447–0002, Phone:
202–401–2344, E-mail:
tichappelle@acf.hhs.gov.
VIII. Other Information
Notice: Beginning with FY 2006, the
Administration for Children and
Families (ACF) will no longer publish
grant announcements in the Federal
Register. Beginning October 1, 2005
applicants will be able to find a
synopsis of all ACF grant opportunities
and apply electronically for
opportunities via: www.Grants.gov.
Applicants will also be able to find the
complete text of all ACF grant
announcements on the ACF Web site
located at: https://www.acf.hhs.gov/
grants/.
Training and Technical Assistance
(T&TA): All potential ANA applicants
are eligible to receive T&TA.
Prospective applicants should check
ANA’s Web site for training and
technical assistance dates and locations,
or contact the ANA Help Desk at 1–877–
922–9262.
Please reference Section IV.3 for
details about acknowledgement of
received applications.
Dated: May 24, 2005.
Kimberly Romine,
Deputy Commissioner, Administration for
Native Americans.
[FR Doc. 05–11279 Filed 6–6–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0526]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry: Fast Track Drug
Development Programs—Designation,
Development, and Application Review
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Program Office Contact
33177
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
E:\FR\FM\07JNN1.SGM
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33178
Federal Register / Vol. 70, No. 108 / Tuesday, June 7, 2005 / Notices
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 7,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
Guidance for Industry: Fast Track Drug
Development Programs—Designation,
Development, and Application
Review—(OMB Control Number 0910–
0389)—Extension
Section 112(a) of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Public Law 105–115)
amended the Federal Food, Drug, and
Cosmetic Act (the act) by adding section
506 (21 U.S.C. 356). The section
authorizes FDA to take appropriate
action to facilitate the development and
expedite the review of new drugs,
including biological products, intended
to treat a serious or life-threatening
condition and that demonstrate a
potential to address an unmet medical
need. Under FDAMA section 112(b),
FDA issued guidance to industry on fast
track policies and procedures outlined
in section 506 of the act. The guidance
discusses collections of information that
are specified under section 506 of the
act, other sections of the Public Health
Service Act (the PHS Act), or
implementing regulations. The guidance
describes three general areas involving
the following collection of information:
(1) Fast track designation requests, (2)
premeeting packages, and (3) requests to
submit portions of an application. Of
these, fast track designation requests
and premeeting packages, in support of
receiving a fast track program benefit,
provide for additional collections of
information not covered elsewhere in
statute or regulation. Information in
support of fast track designation or fast
track program benefits that has
VerDate jul<14>2003
20:54 Jun 06, 2005
Jkt 205001
previously been submitted to the
agency, may, in some cases, be
incorporated into the request by
referring to the information rather than
resubmitting it.
Under section 506(a)(1) of the act, an
applicant who seeks fast track
designation is required to submit a
request to the agency showing that the
product may do the following: (1) Is
intended for a serious or life-threatening
condition and (2) the product has the
potential to address an unmet medical
need. Mostly, the agency expects that
information to support a designation
request will have been gathered under
existing provisions of the act, the PHS
Act, or implementing regulations. If
such information has already been
submitted to the agency, the information
may be summarized in the fast track
designation request. The guidance
recommends that a designation request
include, where applicable, additional
information not specified elsewhere by
statute or regulation. For example,
additional information may be needed
to show that a product has the potential
to address an unmet medical need
where an approved therapy exists for
the serious or life-threatening condition
to be treated. Such information may
include clinical data, published reports,
summaries of data and reports, and a list
of references. The amount of
information and discussion in a
designation request need not be
voluminous, but it should be sufficient
to permit a reviewer to assess whether
the criteria for fast track designation
have been met.
After the agency makes a fast track
designation, a sponsor or applicant may
submit a premeeting package, which
may include additional information
supporting a request to participate in
certain fast track programs. The
premeeting package serves as
background information for the meeting
and should support the intended
objectives of the meeting. As with the
request for fast track designation, the
agency expects that most sponsors or
applicants will have already gathered
such information to meet existing
requirements under the act, the PHS
Act, or implementing regulations. These
may include descriptions of clinical
safety and efficacy trials not conducted
under an investigational new drug
application (IND) (i.e., foreign studies),
and information to support a request for
accelerated approval. If such
information has already been submitted
to FDA the information may be
summarized in the premeeting package.
Consequently, FDA anticipates that the
additional collection of information
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Sfmt 4703
attributed solely to the guidance will be
minimal.
Under section 506(c) of the act, a
sponsor must submit sufficient clinical
data for the agency to determine, after
preliminary evaluation, that a fast track
product may be effective. Section 506(c)
also requires that an applicant provide
a schedule for the submission of
information necessary to make the
application complete before FDA can
commence its review. The guidance
does not provide for any new collection
of information regarding the submission
of portions of an application that is not
required under section 506(c) of the act
or any other provision of the act. All
forms referred to in the guidance have
a current OMB approval: FDA Forms
1571 (OMB control number 0910–0014,
expires January 31, 2006); 356h (OMB
control number 0910–0338, expires
August 31, 2005); and 3397 (OMB
control number 0910–0297, expires
December 31, 2006).
Respondents to this information
collection are sponsors and applicants
who seek fast track designation under
section 506 of the act. The agency
estimates the total annual number of
respondents submitting requests for fast
track designation to the Center for
Biologics Evaluation and Research
(CBER) and the Center for Drug
Evaluation and Research (CDER) will be
approximately 56. To obtain this
estimate, FDA averaged the number of
requests for fast track designation
received by CBER and CDER in the 3year period from 2001 to 2003. For these
3 years, CBER and CDER together
received a yearly average of 67 requests
from 56 respondents. The rate of
submissions is not expected to change
significantly in the next few years. FDA
estimates that the number of hours
needed to prepare a request for fast track
designation may range between 40 and
80 hours per request, depending on the
complexity of each request, with an
average of 60 hours per request, as
indicated in table 1 of this document.
Not all requests for fast track
designation may meet the statutory
standard. Of the average 67 requests
made per year, the agency granted 47
requests for fast track designation. For
each of the 47 granted requests, FDA
estimates that a premeeting package was
submitted to the agency. FDA estimates
that the preparation hours may
generally range between 80 and 120
hours, with an average of 100 hours per
package, as indicated in table 1 of this
document.
In the Federal Register of December
13, 2004 (69 FR 72202), FDA published
a 60-day notice requesting public
comment on the information collection
E:\FR\FM\07JNN1.SGM
07JNN1
33179
Federal Register / Vol. 70, No. 108 / Tuesday, June 7, 2005 / Notices
provisions. One comment was received
but was not related to the information
collection.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Reporting Activity
Number of Respondents
Annual Frequency per
Response
Total Annual Responses
Hours per
Respondent
Total Hours
Designation Request
56
1.20
67
60
4,020
Premeeting Packages
47
1.00
47
100
4,700
Total
8,720
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–11206 Filed 6–6–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0251]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requests for
Inspection by an Accredited Person
Under the Inspection by Accredited
Persons Program
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 July 7,
2005.
The Office of Management
and Budget (OMB) is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
ADDRESSES:
VerDate jul<14>2003
20:54 Jun 06, 2005
Jkt 205001
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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.
Requests for Inspection by an
Accredited Person under the Inspection
by Accredited Persons Program
Section 201 of the Medical Device
User Fee and Modernization Act of 2002
(MDUFMA) (Public Law 107–250)
amends section 704 of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 374) by adding paragraph (g).
This amendment authorizes FDA to
establish a voluntary third party
inspection program applicable to
manufacturers of class II or class III
medical devices who meet certain
eligibility criteria. Under this new
Inspection by Accredited Persons
Program (AP program), such
manufacturers may elect to have third
parties that have been accredited by
FDA (accredited person or AP) conduct
some of their inspections instead of
FDA.
The AP program applies to
manufacturers who currently market
their medical devices in the United
States and who also market or plan to
market their devices in foreign
countries. Such manufacturers may
need current inspections of their
establishments to operate in global
commerce.
The applicant must submit the
following information in support of a
request for approval to use an AP:
• Information that shows that the
applicant ‘‘manufactures, prepares,
propagates, compounds, or processes’’
class II or class III medical devices.
• Information that shows that the
applicant markets at least one of the
devices in the United States.
• Information that shows that the
applicant markets or intends to market
at least one of the devices in one or
PO 00000
Frm 00125
Fmt 4703
Sfmt 4703
more foreign countries and one or both
of the following two conditions are met
as follows:
1. One of the foreign countries
certifies, accredits, or otherwise
recognizes the AP the applicant has
selected as a person authorized to
conduct inspections of device
establishments; or
2. A statement that the law of a
country where the applicant markets or
intends to market the device recognizes
an inspection by the FDA or by the AP.
• Information that shows that the
applicant’s most recent inspection
performed by FDA, or by an AP under
this program, was classified by FDA as
either ‘‘No Action Indicated (NAI)’’ or
‘‘Voluntary Action Indicated (VAI);’’
and
• A notice to FDA requesting
clearance (approval) to use an AP, and
identifying the AP the applicant
selected.
In the Federal Register of June 3, 2004
(69 FR 31397 at 31398), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. FDA received one comment
concerning the potential burden
associated with the third party
inspectional program application
process if related cumulative partial
inspections over a 2-year period were
not recognized by FDA as a single
comprehensive inspection. FDA
clarified the guidance to state that
manufacturers may rely on a single
comprehensive inspection or a serious
of partial inspections that would
cumulatively constitute a complete
inspection for the purposes of meeting
FDA’s biennial inspection requirement.
Reapplication to the FDA AP inspection
program will not be necessary to
conduct each related partial inspection
that cumulatively constitutes a single
comprehensive inspection of an
establishment.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\07JNN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 108 (Tuesday, June 7, 2005)]
[Notices]
[Pages 33177-33179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0526]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Fast Track Drug Development Programs--Designation,
Development, and Application Review
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
[[Page 33178]]
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 7,
2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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.
Guidance for Industry: Fast Track Drug Development Programs--
Designation, Development, and Application Review--(OMB Control Number
0910-0389)--Extension
Section 112(a) of the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Public Law 105-115) amended the Federal Food,
Drug, and Cosmetic Act (the act) by adding section 506 (21 U.S.C. 356).
The section authorizes FDA to take appropriate action to facilitate the
development and expedite the review of new drugs, including biological
products, intended to treat a serious or life-threatening condition and
that demonstrate a potential to address an unmet medical need. Under
FDAMA section 112(b), FDA issued guidance to industry on fast track
policies and procedures outlined in section 506 of the act. The
guidance discusses collections of information that are specified under
section 506 of the act, other sections of the Public Health Service Act
(the PHS Act), or implementing regulations. The guidance describes
three general areas involving the following collection of information:
(1) Fast track designation requests, (2) premeeting packages, and (3)
requests to submit portions of an application. Of these, fast track
designation requests and premeeting packages, in support of receiving a
fast track program benefit, provide for additional collections of
information not covered elsewhere in statute or regulation. Information
in support of fast track designation or fast track program benefits
that has previously been submitted to the agency, may, in some cases,
be incorporated into the request by referring to the information rather
than resubmitting it.
Under section 506(a)(1) of the act, an applicant who seeks fast
track designation is required to submit a request to the agency showing
that the product may do the following: (1) Is intended for a serious or
life-threatening condition and (2) the product has the potential to
address an unmet medical need. Mostly, the agency expects that
information to support a designation request will have been gathered
under existing provisions of the act, the PHS Act, or implementing
regulations. If such information has already been submitted to the
agency, the information may be summarized in the fast track designation
request. The guidance recommends that a designation request include,
where applicable, additional information not specified elsewhere by
statute or regulation. For example, additional information may be
needed to show that a product has the potential to address an unmet
medical need where an approved therapy exists for the serious or life-
threatening condition to be treated. Such information may include
clinical data, published reports, summaries of data and reports, and a
list of references. The amount of information and discussion in a
designation request need not be voluminous, but it should be sufficient
to permit a reviewer to assess whether the criteria for fast track
designation have been met.
After the agency makes a fast track designation, a sponsor or
applicant may submit a premeeting package, which may include additional
information supporting a request to participate in certain fast track
programs. The premeeting package serves as background information for
the meeting and should support the intended objectives of the meeting.
As with the request for fast track designation, the agency expects that
most sponsors or applicants will have already gathered such information
to meet existing requirements under the act, the PHS Act, or
implementing regulations. These may include descriptions of clinical
safety and efficacy trials not conducted under an investigational new
drug application (IND) (i.e., foreign studies), and information to
support a request for accelerated approval. If such information has
already been submitted to FDA the information may be summarized in the
premeeting package. Consequently, FDA anticipates that the additional
collection of information attributed solely to the guidance will be
minimal.
Under section 506(c) of the act, a sponsor must submit sufficient
clinical data for the agency to determine, after preliminary
evaluation, that a fast track product may be effective. Section 506(c)
also requires that an applicant provide a schedule for the submission
of information necessary to make the application complete before FDA
can commence its review. The guidance does not provide for any new
collection of information regarding the submission of portions of an
application that is not required under section 506(c) of the act or any
other provision of the act. All forms referred to in the guidance have
a current OMB approval: FDA Forms 1571 (OMB control number 0910-0014,
expires January 31, 2006); 356h (OMB control number 0910-0338, expires
August 31, 2005); and 3397 (OMB control number 0910-0297, expires
December 31, 2006).
Respondents to this information collection are sponsors and
applicants who seek fast track designation under section 506 of the
act. The agency estimates the total annual number of respondents
submitting requests for fast track designation to the Center for
Biologics Evaluation and Research (CBER) and the Center for Drug
Evaluation and Research (CDER) will be approximately 56. To obtain this
estimate, FDA averaged the number of requests for fast track
designation received by CBER and CDER in the 3-year period from 2001 to
2003. For these 3 years, CBER and CDER together received a yearly
average of 67 requests from 56 respondents. The rate of submissions is
not expected to change significantly in the next few years. FDA
estimates that the number of hours needed to prepare a request for fast
track designation may range between 40 and 80 hours per request,
depending on the complexity of each request, with an average of 60
hours per request, as indicated in table 1 of this document.
Not all requests for fast track designation may meet the statutory
standard. Of the average 67 requests made per year, the agency granted
47 requests for fast track designation. For each of the 47 granted
requests, FDA estimates that a premeeting package was submitted to the
agency. FDA estimates that the preparation hours may generally range
between 80 and 120 hours, with an average of 100 hours per package, as
indicated in table 1 of this document.
In the Federal Register of December 13, 2004 (69 FR 72202), FDA
published a 60-day notice requesting public comment on the information
collection
[[Page 33179]]
provisions. One comment was received but was not related to the
information collection.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual Hours per
Reporting Activity Number of Respondents Response Responses Respondent Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designation Request 56 1.20 67 60 4,020
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premeeting Packages 47 1.00 47 100 4,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ........................ ........................ ................. ............ 8,720
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11206 Filed 6-6-05; 8:45 am]
BILLING CODE 4160-01-S
