80_FR_54744 80 FR 54569 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; New Animal Drugs for Investigational Use

80 FR 54569 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; New Animal Drugs for Investigational Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 175 (September 10, 2015)

Page Range54569-54570
FR Document2015-22830

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.

Federal Register, Volume 80 Issue 175 (Thursday, September 10, 2015) 
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54569-54570]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22830]


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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.

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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, [email protected].

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 http://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

Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices 54569 comments. Identify comments with the 1996’’ (Pub. L. 104–134, amended by for the same product(s) in response to docket number found in brackets in the Pub. L. 104–180) amended sections the same request generally cost FDA less heading of this document. Received 801(e) and 802 of the Federal Food, than $175 to prepare. The fee for all comments may be seen in the Division Drug, and Cosmetic Act (the FD&C Act) subsequent certificates for the same of Dockets Management between 9 a.m. (21 U.S.C. 381(e) and 382). It was product(s) issued in response to the and 4 p.m., Monday through Friday, and designed to ease restrictions on same request reflects reduced FDA costs will be posted to the docket at http:// exportation of unapproved for preparing those certificates. www.regulations.gov. pharmaceuticals, biologics, and devices The following fees will be assessed regulated by FDA. Section 801(e)(4) of starting October 1, 2015, for animal food V. Electronic Access the FD&C Act provides that persons export certificates: Persons with access to the Internet exporting certain FDA regulated may obtain the draft guidance at either products may request FDA to certify TABLE 1—CVM FEES FOR FIRST, http://www.fda.gov/AnimalVeterinary/ that the products meet the requirements SECOND, AND SUBSEQUENT EXPORT GuidanceComplianceEnforcement/ of section 801(e)(1), section 802, or CERTIFICATES GuidanceforIndustry/default.htm or other applicable requirements of the http://www.regulations.gov. FD&C Act. Section 801(e)(4) of the Type of certificate Fee FD&C Act also requires FDA to issue (dollars) Dated: September 1, 2015. Leslie Kux, certification within 20 days of receipt of First certificate ...................... 175 the request and authorizes us to charge Associate Commissioner for Policy. Second certificate for the up to $175 for each certification issued same product(s) issued in [FR Doc. 2015–22772 Filed 9–9–15; 8:45 am] within 20 days. In January 2011, section response to the same re- BILLING CODE 4164–01–P 801(e)(4)(A) of the FD&C Act was quest ................................. 155 amended by FSMA (Pub. L. 111–353) to Subsequent certificates for provide authorization for export the same product(s) DEPARTMENT OF HEALTH AND certification fees for regulated food, issued in response to the HUMAN SERVICES including animal food (referred to as same request .................... 70 animal feed in section 107(b) of FSMA). Food and Drug Administration The fee for issuing the first export Section 801(e)(4) of the FD&C Act [Docket No. FDA–2015–N–3106] authorizes FDA to issue export certificate for animal food will be at the certificates for regulated food, drugs, maximum allowable amount and Animal Food; Export Certificates; Food and devices that are legally marketed in consistent with the export certification and Drug Administration Food Safety the United States, as well as for these fees assessed since FY 1997 by other Modernization Act of 2011; same products that are not legally FDA Centers that provide export Certification Fees marketed but are legally exported under certification for drugs and devices. The section 801(e) or 802 of the FD&C Act. fees for issuing subsequent certificates AGENCY: Food and Drug Administration, continue to differ among the Centers, HHS. The focus of this notice is on export certificates issued by the Center for based on varying costs. ACTION: Notice. Veterinary Medicine (CVM) for animal Dated: September 1, 2015. SUMMARY: The Food and Drug food. Leslie Kux, Administration (FDA or we) is II. Fees To Be Assessed for Export Associate Commissioner for Policy. announcing the fees we will assess for Certificates [FR Doc. 2015–22795 Filed 9–9–15; 8:45 am] issuing export certificates for animal BILLING CODE 4164–01–P food. The FDA Food Safety CVM estimates the costs of the export Modernization Act (FSMA) of 2011 certification program for animal food to authorizes us to charge fees to cover our be approximately $548,000 per year for DEPARTMENT OF HEALTH AND payroll and operating expenses. There HUMAN SERVICES costs associated with issuing export are four cost categories for preparing certificates for regulated food including and issuing export certificates in Food and Drug Administration animal food. This notice provides the general. They are: (1) Direct personnel fee schedule for issuing these [Docket No. FDA–2011–N–0481] for research, review, tracking, writing, certificates and the basis for the fees. We and assembly; (2) purchase of Agency Information Collection have not previously collected fees to equipment and supplies used for issue export certificates for animal food. Activities; Announcement of Office of tracking, processing, printing, and DATES: The fees described in this Management and Budget Approval; packaging. Recovery of the cost of the document for export certificates for New Animal Drugs for Investigational equipment is calculated over its useful animal food will be effective October 1, Use life; (3) billing and collection of fees; 2015. and (4) overhead and administrative AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: support. In fiscal year (FY) 2014 CVM HHS. Joanne Kla, Office of Surveillance and issued approximately 933 animal food ACTION: Notice. Compliance, Center for Veterinary export certificates. Because CVM has Medicine (HFV–235), Food and Drug not been charging fees for issuing export SUMMARY: The Food and Drug Administration (FDA) is announcing mstockstill on DSK4VPTVN1PROD with NOTICES Administration, 7500 Standish Pl., certificates for animal food, the program Rockville, MD 20855, 240–402–5605, has been covered by appropriated funds. that a collection of information entitled, CVMExportCertification@fda.hhs.gov. As mentioned previously in this ‘‘New Animal Drugs for Investigational SUPPLEMENTARY INFORMATION: document, FDA may charge up to $175 Use’’ has been approved by the Office of for each certificate. Certificates for some Management and Budget (OMB) under I. Background classes of products, including animal the Paperwork Reduction Act of 1995. In April 1996, a law entitled the ‘‘FDA food, cost the Agency more than $175 to FOR FURTHER INFORMATION CONTACT: FDA Export Reform and Enhancement Act of prepare. Subsequent certificates issued PRA Staff, Office of Operations, Food VerDate Sep<11>2014 17:28 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1

54570 Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices and Drug Administration, 8455 Name of Committee: NIDCR Special Grants Dated: September 4, 2015. Colesville Rd., COLE–14526, Silver Review Committee. Melanie J. Gray, Spring, MD 20993–0002, PRAStaff@ Date: October 22–23, 2015. Time: 8:00 a.m. to 12:30 p.m. Program Analyst, Office of Federal Advisory fda.hhs.gov. Committee Policy. Agenda: To review and evaluate grant SUPPLEMENTARY INFORMATION: On July applications. [FR Doc. 2015–22801 Filed 9–9–15; 8:45 am] 14, 2015, the Agency submitted a Place: National Institutes of Health, One BILLING CODE 4140–01–P proposed collection of information Democracy Plaza, Conference Room #602, entitled, ‘‘New Animal Drugs for 6701 Democracy Boulevard, Bethesda, MD Investigational Use’’ to OMB for review 20892. Contact Person: Marilyn Moore-Hoon, DEPARTMENT OF HEALTH AND and clearance under 44 U.S.C. 3507. An Ph.D., Scientific Review Officer, Scientific HUMAN SERVICES Agency may not conduct or sponsor, Review Branch, National Institute of Dental and a person is not required to respond and Craniofacial Research, 6701 Democracy National Institutes of Health to, a collection of information unless it Blvd., Rm. 676, Bethesda, MD 20892–4878, displays a currently valid OMB control 301–594–4861, mooremar@nidcr.nih.gov. Eunice Kennedy Shriver National number. OMB has now approved the (Catalogue of Federal Domestic Assistance Institute of Child Health and Human information collection and has assigned Program Nos. 93.121, Oral Diseases and Development; Notice of Closed OMB control number 0910–0117. The Disorders Research, National Institutes of Meeting approval expires on August 31, 2018. A Health, HHS) copy of the supporting statement for this Dated: September 3, 2015. Pursuant to section 10(d) of the information collection is available on David Clary, Federal Advisory Committee Act, as the Internet at http://www.reginfo.gov/ amended (5 U.S.C. App.), notice is Program Analyst, Office of Federal Advisory public/do/PRAMain. Committee Policy. hereby given of the following meeting. Dated: September 4, 2015. [FR Doc. 2015–22769 Filed 9–9–15; 8:45 am] The meeting will be closed to the Leslie Kux, BILLING CODE 4140–01–P public in accordance with the Associate Commissioner for Policy. provisions set forth in section 552b(c)(4) [FR Doc. 2015–22830 Filed 9–9–15; 8:45 am] and 552b(c)(6), Title 5 U.S.C., as BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND amended. The grant applications and HUMAN SERVICES the discussions could disclose confidential trade secrets or commercial DEPARTMENT OF HEALTH AND National Institutes of Health property such as patentable material, HUMAN SERVICES and personal information concerning National Institute on Aging; Notice of National Institutes of Health Closed Meeting individuals associated with the grant applications, the disclosure of which Pursuant to section 10(d) of the would constitute a clearly unwarranted National Institute of Dental and Federal Advisory Committee Act, as Craniofacial Research; Notice of invasion of personal privacy. amended (5 U.S.C. App.), notice is Closed Meetings Name of Committee: National Institute of hereby given of the following meeting. Pursuant to section 10(d) of the The meeting will be closed to the Child Health and Human Development Federal Advisory Committee Act, as public in accordance with the Special Emphasis Panel. amended (5 U.S.C. App.), notice is provisions set forth in sections Date: November 18, 2015. hereby given of the following meetings. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 1:30 p.m. to 4:30 p.m. The meetings will be closed to the as amended. The grant applications and Agenda: To review and evaluate grant public in accordance with the the discussions could disclose applications. provisions set forth in sections confidential trade secrets or commercial Place: National Institutes of Health, 6100 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., property such as patentable material, Executive Boulevard, Rockville, MD 20852, as amended. The grant applications and and personal information concerning (Telephone Conference Call). the discussions could disclose individuals associated with the grant Contact Person: Peter Zelazowski, Ph.D., confidential trade secrets or commercial applications, the disclosure of which Scientific Review Officer, Scientific Review property such as patentable material, would constitute a clearly unwarranted Branch, Eunice Kennedy Shriver National and personal information concerning invasion of personal privacy. Institute of Child Health and Human individuals associated with the grant Development, NIH, 6100 Executive Name of Committee: National Institute on Boulevard, Room 5B01, Bethesda, MD applications, the disclosure of which Aging Special Emphasis Panel; Thymic would constitute a clearly unwarranted 20892–9304, (301) 435–6902, Aspects of T Cell Aging. peter.zelazowski@.nih.gov. invasion of personal privacy. Date: November 6, 2015. Time: 1 p.m. to 5 p.m. (Catalogue of Federal Domestic Assistance Name of Committee: National Institute of Agenda: To review and evaluate grant Program Nos. 93.864, Population Research; Dental and Craniofacial Research Special applications. 93.865, Research for Mothers and Children; Emphasis Panel; NIDCR Clinical Trials SEP. Date: October 8, 2015. Place: National Institute on Aging, 93.929, Center for Medical Rehabilitation Time: 8:00 a.m. to 5:00 p.m. Gateway Building, 2C212, 7201 Wisconsin Research; 93.209, Contraception and Agenda: To review and evaluate grant Avenue, Bethesda, MD 20892 (Telephone Infertility Loan Repayment Program, National Conference Call). mstockstill on DSK4VPTVN1PROD with NOTICES applications. Institutes of Health, HHS) Place: Hilton Garden Inn Bethesda, 7301 Contact Person: Isis S. Mikhail, MD, MPH, Waverly Street, Bethesda, MD 20814. DRPH, National Institute on Aging, Gateway Dated: September 3, 2015. Contact Person: Crina Frincu, Ph.D., Building, 7201 Wisconsin Avenue, Suite Michelle Trout, Scientific Review Officer, Scientific Review 2C212, Bethesda, MD 20892, 301–402–7704, MIKHAILI@MAIL.NIH.GOV. Program Analyst, Office of Federal Advisory Branch, National Institute of Dental and Committee Policy. Craniofacial Research, National Institutes of (Catalogue of Federal Domestic Assistance Health, 6701 Democracy Blvd., Suite 662, Program Nos. 93.866, Aging Research, [FR Doc. 2015–22706 Filed 9–9–15; 8:45 am] Bethesda, MD 20892, cfrincu@mail.nih.gov. National Institutes of Health, HHS) BILLING CODE 4140–01–P VerDate Sep<11>2014 17:28 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 9990 E:\FR\FM\10SEN1.SGM 10SEN1


Document Created: 2015-12-15 10:03:21
Document Modified: 2015-12-15 10:03:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 54569 
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