Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion, 46954-46955 [2013-18573]
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Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
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sroberts on DSK5SPTVN1PROD with NOTICES
Inquiries
Please direct all inquiries to:
Technical Information Management
Section, Procurement and Grants Office,
Centers for Disease Control and
Prevention, Telephone: 770–488–2700,
Email: pgotim@cdc.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2013–N–0868]
[Docket No. FDA–2012–N–0536]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Device User Fee Cover Sheet,
Form FDA 3601
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Device User Fee Cover Sheet,
Form FDA 3601’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
On
February 8, 2013, the Agency submitted
a proposed collection of information
entitled ‘‘Medical Device User Fee
Cover Sheet, Form FDA 3601’’ to OMB
for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0511. The
approval expires on April 30, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
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Food and Drug Administration,
HHS.
Notice.
Dated: July 26, 2013.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
VerDate Mar<15>2010
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Draft Guidance for
Industry: Use of Serological Tests To
Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Whole
Blood and Blood Components for
Transfusion
Sfmt 4703
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
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 establishment notification of
a consignee and consignee notification
of a recipient’s physician of record
regarding a possible increased risk of
Trypanosoma cruzi (T. cruzi) infection.
DATES: Submit either electronic or
written comments on the collection of
information by October 1, 2013.
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: 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: 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
SUMMARY:
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Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
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.
Guidance for Industry: Use of
Serological Tests To Reduce the Risk of
Transmission of Trypanosoma cruzi
Infection in Whole Blood and Blood
Components for Transfusion—(OMB
Control Number 0910–0681)—Extension
The guidance implements the donor
screening recommendations for the
FDA-approved serological test systems
for the detection of antibodies to T.
cruzi. The use of the donor screening
tests are to reduce the risk of
transmission of T. cruzi infection by
detecting antibodies to T. cruzi in
plasma and serum samples from
individual human donors, including
donors of Whole Blood and Blood
Components intended for transfusion.
The guidance recommends that
establishments that manufacture Whole
Blood and Blood Components intended
for transfusion should notify consignees
of all previously collected in-date blood
and blood components to quarantine
and return the blood components to
establishments or to destroy them
within three calendar days after a donor
tests repeatedly reactive by a licensed
test for T. cruzi antibody. When
establishments identify a donor who is
repeatedly reactive by a licensed test for
T. cruzi antibodies and for whom there
is additional information indicating risk
VerDate Mar<15>2010
18:55 Aug 01, 2013
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of T. cruzi infection, such as testing
positive on a licensed supplemental test
(when such test is available) or until
such test is available, information that
the donor or donor’s mother resided in
an area endemic for Chagas disease
(Mexico, Central and South America) or
as a result of other medical diagnostic
testing of the donor indicating T. cruzi
infection, we recommend that the
establishment notify consignees of all
previously distributed blood and blood
components collected during the
‘‘lookback’’ period and, if blood and
blood components were transfused,
encourage consignees to notify the
recipient’s physician of record of a
possible increased risk of T. cruzi
infection.
Respondents to this information
collection are establishments that
manufacture Whole Blood and Blood
Components intended for transfusion.
We believe that the information
collection provisions in the guidance for
establishments to notify consignees and
for consignees to notify the recipient’s
physician of record do not create a new
burden for respondents and are part of
usual and customary business practices.
Since the end of January 2007, a number
of blood centers representing a large
proportion of U.S. blood collections
have been testing donors using a
licensed assay. We believe these
establishments have already developed
standard operating procedures for
notifying consignees and the consignees
to notify the recipient’s physician of
record.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
601.12 have been approved under OMB
control number 0910–0338; the
collections of information in 21 CFR
606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), 610.40, and
630.6 have been approved under OMB
control number 0910–0116; the
collections of information in 21 CFR
606.171 have been approved under
OMB control number 0910–0458.
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18573 Filed 8–1–13; 8:45 am]
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46955
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0007]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2014
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates and payment procedures for fiscal
year (FY) 2014 animal drug user fees.
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Animal Drug User Fee Amendments of
2013, which was signed by the
President on June 13, 2013 (ADUFA III),
authorizes FDA to collect user fees for
certain animal drug applications and
supplements, for certain animal drug
products, for certain establishments
where such products are made, and for
certain sponsors of such animal drug
applications and/or investigational
animal drug submissions. This notice
establishes the fee rates for FY 2014.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/
AnimalDrugUserFeeActADUFA/
default.htm or contact Lisa Kable,
Center for Veterinary Medicine (HFV–
10), Food and Drug Administration,
7529 Standish Pl., Rockville, MD 20855,
240–276–9718. For general questions,
you may also email the Center for
Veterinary Medicine (CVM) at:
cvmadufa@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the FD&C Act (21
U.S.C. 379j–12) establishes four
different types of user fees: (1) Fees for
certain types of animal drug
applications and supplements; (2)
annual fees for certain animal drug
products; (3) annual fees for certain
establishments where such products are
made; and (4) annual fees for certain
sponsors of animal drug applications
and/or investigational animal drug
submissions (21 U.S.C. 379j–12(a)).
When certain conditions are met, FDA
will waive or reduce fees (21 U.S.C.
379j–12(d)).
For FY 2014 through FY 2018, the
FD&C Act establishes aggregate yearly
base revenue amounts for each fiscal
year (21 U.S.C. 379j–12(b)(1)). Base
revenue amounts established for years
after FY 2014 are subject to adjustment
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]]>Agencies
[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46954-46955]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18573]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0868]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Draft Guidance for Industry: Use of Serological Tests
To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in
Whole Blood and Blood Components for Transfusion
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 establishment
notification of a consignee and consignee notification of a recipient's
physician of record regarding a possible increased risk of Trypanosoma
cruzi (T. cruzi) infection.
DATES: Submit either electronic or written comments on the collection
of information by October 1, 2013.
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: 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: 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
[[Page 46955]]
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.
Guidance for Industry: Use of Serological Tests To Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood
Components for Transfusion--(OMB Control Number 0910-0681)--Extension
The guidance implements the donor screening recommendations for the
FDA-approved serological test systems for the detection of antibodies
to T. cruzi. The use of the donor screening tests are to reduce the
risk of transmission of T. cruzi infection by detecting antibodies to
T. cruzi in plasma and serum samples from individual human donors,
including donors of Whole Blood and Blood Components intended for
transfusion. The guidance recommends that establishments that
manufacture Whole Blood and Blood Components intended for transfusion
should notify consignees of all previously collected in-date blood and
blood components to quarantine and return the blood components to
establishments or to destroy them within three calendar days after a
donor tests repeatedly reactive by a licensed test for T. cruzi
antibody. When establishments identify a donor who is repeatedly
reactive by a licensed test for T. cruzi antibodies and for whom there
is additional information indicating risk of T. cruzi infection, such
as testing positive on a licensed supplemental test (when such test is
available) or until such test is available, information that the donor
or donor's mother resided in an area endemic for Chagas disease
(Mexico, Central and South America) or as a result of other medical
diagnostic testing of the donor indicating T. cruzi infection, we
recommend that the establishment notify consignees of all previously
distributed blood and blood components collected during the
``lookback'' period and, if blood and blood components were transfused,
encourage consignees to notify the recipient's physician of record of a
possible increased risk of T. cruzi infection.
Respondents to this information collection are establishments that
manufacture Whole Blood and Blood Components intended for transfusion.
We believe that the information collection provisions in the guidance
for establishments to notify consignees and for consignees to notify
the recipient's physician of record do not create a new burden for
respondents and are part of usual and customary business practices.
Since the end of January 2007, a number of blood centers representing a
large proportion of U.S. blood collections have been testing donors
using a licensed assay. We believe these establishments have already
developed standard operating procedures for notifying consignees and
the consignees to notify the recipient's physician of record.
The guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR 601.12 have been approved under OMB control number 0910-0338;
the collections of information in 21 CFR 606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), 610.40, and 630.6 have been approved under
OMB control number 0910-0116; the collections of information in 21 CFR
606.171 have been approved under OMB control number 0910-0458.
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18573 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P
