Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; New Animal Drugs for Investigational Use, 54569-54570 [2015-22830]
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54569
Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: September 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22772 Filed 9–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3106]
Animal Food; Export Certificates; Food
and Drug Administration Food Safety
Modernization Act of 2011;
Certification Fees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the fees we will assess for
issuing export certificates for animal
food. The FDA Food Safety
Modernization Act (FSMA) of 2011
authorizes us to charge fees to cover our
costs associated with issuing export
certificates for regulated food including
animal food. This notice provides the
fee schedule for issuing these
certificates and the basis for the fees. We
have not previously collected fees to
issue export certificates for animal food.
DATES: The fees described in this
document for export certificates for
animal food will be effective October 1,
2015.
FOR FURTHER INFORMATION CONTACT:
Joanne Kla, Office of Surveillance and
Compliance, Center for Veterinary
Medicine (HFV–235), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5605,
CVMExportCertification@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
In April 1996, a law entitled the ‘‘FDA
Export Reform and Enhancement Act of
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1996’’ (Pub. L. 104–134, amended by
Pub. L. 104–180) amended sections
801(e) and 802 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 381(e) and 382). It was
designed to ease restrictions on
exportation of unapproved
pharmaceuticals, biologics, and devices
regulated by FDA. Section 801(e)(4) of
the FD&C Act provides that persons
exporting certain FDA regulated
products may request FDA to certify
that the products meet the requirements
of section 801(e)(1), section 802, or
other applicable requirements of the
FD&C Act. Section 801(e)(4) of the
FD&C Act also requires FDA to issue
certification within 20 days of receipt of
the request and authorizes us to charge
up to $175 for each certification issued
within 20 days. In January 2011, section
801(e)(4)(A) of the FD&C Act was
amended by FSMA (Pub. L. 111–353) to
provide authorization for export
certification fees for regulated food,
including animal food (referred to as
animal feed in section 107(b) of FSMA).
Section 801(e)(4) of the FD&C Act
authorizes FDA to issue export
certificates for regulated food, drugs,
and devices that are legally marketed in
the United States, as well as for these
same products that are not legally
marketed but are legally exported under
section 801(e) or 802 of the FD&C Act.
The focus of this notice is on export
certificates issued by the Center for
Veterinary Medicine (CVM) for animal
food.
II. Fees To Be Assessed for Export
Certificates
CVM estimates the costs of the export
certification program for animal food to
be approximately $548,000 per year for
payroll and operating expenses. There
are four cost categories for preparing
and issuing export certificates in
general. They are: (1) Direct personnel
for research, review, tracking, writing,
and assembly; (2) purchase of
equipment and supplies used for
tracking, processing, printing, and
packaging. Recovery of the cost of the
equipment is calculated over its useful
life; (3) billing and collection of fees;
and (4) overhead and administrative
support. In fiscal year (FY) 2014 CVM
issued approximately 933 animal food
export certificates. Because CVM has
not been charging fees for issuing export
certificates for animal food, the program
has been covered by appropriated funds.
As mentioned previously in this
document, FDA may charge up to $175
for each certificate. Certificates for some
classes of products, including animal
food, cost the Agency more than $175 to
prepare. Subsequent certificates issued
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for the same product(s) in response to
the same request generally cost FDA less
than $175 to prepare. The fee for all
subsequent certificates for the same
product(s) issued in response to the
same request reflects reduced FDA costs
for preparing those certificates.
The following fees will be assessed
starting October 1, 2015, for animal food
export certificates:
TABLE 1—CVM FEES FOR FIRST,
SECOND, AND SUBSEQUENT EXPORT
CERTIFICATES
Type of certificate
Fee
(dollars)
First certificate ......................
Second certificate for the
same product(s) issued in
response to the same request .................................
Subsequent certificates for
the same product(s)
issued in response to the
same request ....................
175
155
70
The fee for issuing the first export
certificate for animal food will be at the
maximum allowable amount and
consistent with the export certification
fees assessed since FY 1997 by other
FDA Centers that provide export
certification for drugs and devices. The
fees for issuing subsequent certificates
continue to differ among the Centers,
based on varying costs.
Dated: September 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22795 Filed 9–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0481]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
New Animal Drugs for Investigational
Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘New Animal Drugs for Investigational
Use’’ has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
SUMMARY:
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Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On July
14, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘New Animal Drugs for
Investigational Use’’ 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 0910–0117. The
approval expires on August 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Name of Committee: NIDCR Special Grants
Review Committee.
Date: October 22–23, 2015.
Time: 8:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, Conference Room #602,
6701 Democracy Boulevard, Bethesda, MD
20892.
Contact Person: Marilyn Moore-Hoon,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute of Dental
and Craniofacial Research, 6701 Democracy
Blvd., Rm. 676, Bethesda, MD 20892–4878,
301–594–4861, mooremar@nidcr.nih.gov.
Dated: September 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22769 Filed 9–9–15; 8:45 am]
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: September 3, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2015–22830 Filed 9–9–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4164–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute on Aging; Notice of
Closed Meeting
National Institutes of Health
National Institute of Dental and
Craniofacial Research; Notice of
Closed Meetings
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; NIDCR Clinical Trials SEP.
Date: October 8, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Crina Frincu, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute of Dental and
Craniofacial Research, National Institutes of
Health, 6701 Democracy Blvd., Suite 662,
Bethesda, MD 20892, cfrincu@mail.nih.gov.
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Thymic
Aspects of T Cell Aging.
Date: November 6, 2015.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 2C212, 7201 Wisconsin
Avenue, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Isis S. Mikhail, MD, MPH,
DRPH, National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Suite
2C212, Bethesda, MD 20892, 301–402–7704,
MIKHAILI@MAIL.NIH.GOV.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
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Dated: September 4, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–22801 Filed 9–9–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section 552b(c)(4)
and 552b(c)(6), Title 5 U.S.C., as
amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: November 18, 2015.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Peter Zelazowski, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6100 Executive
Boulevard, Room 5B01, Bethesda, MD
20892–9304, (301) 435–6902,
peter.zelazowski@.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: September 3, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–22706 Filed 9–9–15; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54569-54570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22830]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0481]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; New Animal Drugs for Investigational
Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled, ``New Animal Drugs for
Investigational Use'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food
[[Page 54570]]
and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On July 14, 2015, the Agency submitted a
proposed collection of information entitled, ``New Animal Drugs for
Investigational Use'' 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 0910-0117.
The approval expires on August 31, 2018. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: September 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22830 Filed 9-9-15; 8:45 am]
BILLING CODE 4164-01-P