Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions, 23359-23360 [2014-09470]
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23359
Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0220]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Pharmacogenomic Data
Submissions
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 May 28,
2014.
SUMMARY:
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 0910–0557. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Guidance for Industry on
Pharmacogenomic Data Submissions—
(OMB Control Number 0910–0557)—
Extension
The guidance provides
recommendations to sponsors
submitting or holding investigational
new drug applications (INDs), new drug
applications (NDAs), or biologics
license applications (BLAs) on what
pharmacogenomic data should be
submitted to the Agency during the drug
development process. Sponsors holding,
and applicants submitting, INDs, NDAs,
or BLAs are subject to FDA
requirements for submitting to the
Agency data relevant to drug safety and
efficacy (21 CFR 312.22, 312.23, 312.31,
312.33, 314.50, 314.81, 601.2, and
601.12).
The guidance interprets FDA
regulations for IND, NDA, or BLA
submissions, clarifying when the
regulations require pharmacogenomics
data to be submitted and when the
submission of such data is voluntary.
The pharmacogenomic data submissions
described in the guidance that are
required to be submitted to an IND,
NDA, BLA, or annual report are covered
by the information collection
requirements under parts 312, 314, and
601 (21 CFR parts 312, 314, and 601)
and are approved by OMB under control
numbers 0910–0014 (part 312, INDs);
0910–0001 (part 314, NDAs and annual
reports); and 0910–0338 (part 601,
BLAs).
The guidance distinguishes between
pharmacogenomic tests that may be
considered valid biomarkers appropriate
for regulatory decisionmaking, and
other, less well-developed exploratory
tests. The submission of exploratory
pharmacogenomic data is not required
under the regulations, although the
Agency encourages the voluntary
submission of such data.
The guidance describes the voluntary
genomic data submission (VGDS) that
can be used for such a voluntary
submission. The guidance does not
recommend a specific format for the
VGDS, except that such a voluntary
submission be designated as a VGDS.
The data submitted in a VGDS and the
level of detail should be sufficient for
FDA to be able to interpret the
information and independently analyze
the data, verify results, and explore
possible genotype-phenotype
correlations across studies. FDA does
not want the VGDS to be overly
burdensome and time-consuming for the
sponsor.
FDA has estimated the burden of
preparing a voluntary submission
described in the guidance that should be
designated as a VGDS. Based on FDA’s
experience with these submissions over
the past few years, and on FDA’s
familiarity with sponsors’ interest in
submitting pharmacogenomic data
during the drug development process,
FDA estimates that approximately four
sponsors will submit approximately one
VGDS each, and that, on average, each
VGDS will take approximately 50 hours
to prepare and submit to FDA.
In the Federal Register of February 6,
2014 (79 FR 7198), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Voluntary Genomic Data Submissions ................................
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
Number of
responses per
respondent
Number of
respondents
Activity
4
Average
burden per
response
Total annual
responses
1
4
are no capital costs or operating and maintenance costs associated with this collection of information.
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50
Total hours
200
23360
Federal Register / Vol. 79, No. 81 / Monday, April 28, 2014 / Notices
Dated: April 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA–
FD–1–005.
[FR Doc. 2014–09470 Filed 4–25–14; 8:45 am]
BILLING CODE 4160–01–P
Catalog of Federal Domestic Assistance
Number: 93.103
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0411]
Cooperative Agreement To Support the
Illinois Institute of Technology’s
National Center for Food Safety and
Technology
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for a
cooperative agreement in support of the
Illinois Institute of Technology (IIT),
which supports the National Center for
Food Safety and Technology (NCFST).
The estimated amount of support in
Fiscal Year (FY) 14 will be for up to $5
million (direct plus indirect costs), with
the possibility of 4 additional years of
support for up to $20 million, subject to
the availability of funds. This award
will improve public health by continued
support of an applied research,
education, and outreach program related
to the safety of food processing
technologies and processed foods.
DATES: Important dates are as follows:
1. The application due date is June 3,
2014.
2. The anticipated start date is
September 2014.
3. The opening date is May 3, 2014.
4. The expiration date is June 4, 2014.
ADDRESSES: Submit the original paper
application to Gladys Melendez (Bohler)
and a copy to Mickey Parish at the
following addresses: Mickey Parish,
Food and Drug Administration, Center
for Food Safety and Applied Nutrition
(CFSAN), 5100 Paint Branch Pkwy.,
HFS–300, Rm. 3A–0264, College Park,
MD 20740, 240–402–1728,
Mickey.Parish@fda.hhs.gov; and Gladys
Melendez (Bohler), Division of State
Acquisitions, Agreements and Grants,
Food and Drug Administration, (HFA–
500), 5630 Fishers Lane, Rm. 2032,
Rockville, MD 20857, 240–731–3905,
gladys.bohler@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.fda.gov/food/newsevents/
default.htm.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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17:06 Apr 25, 2014
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A. Background
FDA has supported the NCFST under
six previously awarded cooperative
agreements (53 FR 15736; 56 FR 46189;
59 FR 24703; 64 FR 39512; 69 FR 25405;
and 74 FR 26408). NCFST was
established by IIT to bring together the
food safety and technology expertise of
academia, industry, and FDA for the
purpose of supporting research and
outreach efforts related to the safety of
foods based on a common goal of
enhancing the safety of the food supply
for U.S. consumers. NCFST has been
successful in developing research
programs, such as those related to lowmoisture foods, and outreach programs,
such as those related to sprout safety;
these successes were achieved as a
result of NCFST partnering with
industry, academia, and FDA.
NCFST is structured so that
representatives of participating
organizations play a role in establishing
policy and administrative procedures,
as well as identifying long- and shortterm research needs. With this
organizational structure, NCFST is able
to build cooperative food safety
programs on a foundation of knowledge
about current industrial trends in food
processing and packaging technologies,
regulatory perspectives from public
health organizations, and fundamental
scientific expertise from academia. This
award will improve public health by
continued support of an applied
research, education, and outreach
program related to the safety of food
processing technologies and processed
foods.
B. Research Objectives
FDA recognizes that food production
and processing technology is rapidly
changing, that globalization of the food
supply is increasing, and that the
number and nature of the hazards
associated with foods is rapidly
evolving. FDA intends to maintain and
facilitate the further development of
NCFST for the purpose of enhancing
food safety to benefit the public. NCFST
is uniquely positioned as a key
component of FDA’s food protection
program. Specifically, through the
Center’s science platforms the research
at NCFST focuses on the development
and validation of food processing and
packaging technologies for safety and
quality; investigation and development
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of preventive technologies targeted to
reduce or eliminate harmful chemical
and microbial contamination of foods,
and laboratory method performance
(including method validation) to
address issues associated with FDAregulated products. Additionally the
development of an integrated
collaborative food protection research/
education/outreach program will
provide fundamental food safety
information, in the public domain, for
use by all segments of the food science
community in product and process
development, regulatory activities,
academic programs, and consumer
programs.
C. Eligibility Information
Competition is limited to the Illinois
Institute of Technology. FDA believes
that continued support of NCFST at IIT
is appropriate because IIT is uniquely
qualified to fulfill the objectives of the
proposed cooperative agreement. IIT’s
Moffett Center, where NCFST is located,
is a unique research facility that
includes an industrial-size pilot plant
and smaller pilot plants for food
processing and packaging equipment, a
pathogen containment pilot plant, a
packaging laboratory, analytical
laboratories, offices, containment
facilities, classrooms, a distance
learning center, and support facilities,
which permit research from bench top
to industrial scale. The industrial-size
pilot plant is built to accommodate
routine food processing and packaging
research in a commercial atmosphere.
The physical layout of the facility
provides maximum versatility in the use
and arrangement of equipment of both
commercial and pilot size, and in the
capability to simultaneously operate
several different pieces of equipment
without interference with each other.
Additionally, NCFST has a Biosafety
Level 3 pilot plant and laboratory, as
well as a select agent laboratory to
conduct studies with Clostridium
botulinum and other select agents.
Since 1988, IIT has provided an
environment in which scientists from
diverse backgrounds such as academia,
government, and industry have brought
their unique perspectives to focus on
contemporary issues of food safety.
NCFST functions as a neutral ground
where scientific exchange about generic
food safety issues occurs freely and is
channeled into the design of cooperative
food safety programs. NCFST has
become a center of cutting edge
technologies, such as high pressure
processing, cold plasma processing,
pulsed electric field processing, pulsed
light processing, high power ultrasound
processing, microwave processing, and
E:\FR\FM\28APN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Pages 23359-23360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09470]
[[Page 23359]]
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-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0220]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Pharmacogenomic Data Submissions
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 May 28,
2014.
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 0910-0557.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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.
Guidance for Industry on Pharmacogenomic Data Submissions--(OMB Control
Number 0910-0557)--Extension
The guidance provides recommendations to sponsors submitting or
holding investigational new drug applications (INDs), new drug
applications (NDAs), or biologics license applications (BLAs) on what
pharmacogenomic data should be submitted to the Agency during the drug
development process. Sponsors holding, and applicants submitting, INDs,
NDAs, or BLAs are subject to FDA requirements for submitting to the
Agency data relevant to drug safety and efficacy (21 CFR 312.22,
312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).
The guidance interprets FDA regulations for IND, NDA, or BLA
submissions, clarifying when the regulations require pharmacogenomics
data to be submitted and when the submission of such data is voluntary.
The pharmacogenomic data submissions described in the guidance that are
required to be submitted to an IND, NDA, BLA, or annual report are
covered by the information collection requirements under parts 312,
314, and 601 (21 CFR parts 312, 314, and 601) and are approved by OMB
under control numbers 0910-0014 (part 312, INDs); 0910-0001 (part 314,
NDAs and annual reports); and 0910-0338 (part 601, BLAs).
The guidance distinguishes between pharmacogenomic tests that may
be considered valid biomarkers appropriate for regulatory
decisionmaking, and other, less well-developed exploratory tests. The
submission of exploratory pharmacogenomic data is not required under
the regulations, although the Agency encourages the voluntary
submission of such data.
The guidance describes the voluntary genomic data submission (VGDS)
that can be used for such a voluntary submission. The guidance does not
recommend a specific format for the VGDS, except that such a voluntary
submission be designated as a VGDS. The data submitted in a VGDS and
the level of detail should be sufficient for FDA to be able to
interpret the information and independently analyze the data, verify
results, and explore possible genotype-phenotype correlations across
studies. FDA does not want the VGDS to be overly burdensome and time-
consuming for the sponsor.
FDA has estimated the burden of preparing a voluntary submission
described in the guidance that should be designated as a VGDS. Based on
FDA's experience with these submissions over the past few years, and on
FDA's familiarity with sponsors' interest in submitting pharmacogenomic
data during the drug development process, FDA estimates that
approximately four sponsors will submit approximately one VGDS each,
and that, on average, each VGDS will take approximately 50 hours to
prepare and submit to FDA.
In the Federal Register of February 6, 2014 (79 FR 7198), 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 information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Voluntary Genomic Data 4 1 4 50 200
Submissions....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 23360]]
Dated: April 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09470 Filed 4-25-14; 8:45 am]
BILLING CODE 4160-01-P
