Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period, 32963 [2015-14101]

Download as PDF Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices 32963 Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. DEPARTMENT OF HEALTH AND HUMAN SERVICES On April 23, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements’’ 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 0910–0791. The approval expires on May 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. FOR FURTHER INFORMATION CONTACT: John Harshman, Center for Veterinary Medicine, Food and Drug Administration, HFV–170, MPN2, 7500 Standish Pl., Rockville, MD 20855, 240– 402–0845. Food and Drug Administration SUPPLEMENTARY INFORMATION: Dated: June 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14122 Filed 6–9–15; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0684] Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period Food and Drug Administration, HHS. Request for comments; reopening of the comment period. ACTION: The Food and Drug Administration (FDA) is reopening the comment period related to the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence (BE) of nonsystemically absorbed drug products intended for use in veterinary species, published in the Federal Register of March 18, 2015 (80 FR 14146). FDA is reopening the comment period to update comments and to receive any new information. DATES: Submit either electronic or written comments by August 10, 2015. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:46 Jun 09, 2015 Jkt 235001 I. Background Following publication of the March 18, 2015, notification of public meeting and request for comments, FDA received a request to allow interested persons additional time to comment. The requester asserted that the time period of 60 days was insufficient to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues. III. How To Submit Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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. Dated: June 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14101 Filed 6–9–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00035 Fmt 4703 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment of a Tobacco User Panel AGENCY: In the Federal Register of March 18, 2015 (80 FR 14146), FDA announced a public meeting to discuss the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence (BE) of nonsystemically absorbed drug products intended for use in veterinary species. In the same notice, FDA said that it is seeking additional public comment to the docket. Interested persons were originally given until May 18, 2015, to comment on this issue. II. Request for Comments BILLING CODE 4164–01–P AGENCY: SUPPLEMENTARY INFORMATION: [Docket No. FDA–2014–N–1533] Sfmt 4703 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 July 10, 2015. 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–NEW and title ‘‘Establishment of a Tobacco User Panel’’. 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, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, 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. SUMMARY: Establishment of a Tobacco User Panel—(OMB Control Number 0910– NEW) The Food and Drug Administration’s Center for Tobacco Products (CTP) proposes to establish a high quality, probability-based, primarily Web-based, panel of 4,000 tobacco users. The panel will include individuals who can participate in up to 8 studies over a 3year period to assess consumers’ responses to tobacco marketing, warning statements, product labels, and other communications about tobacco products. CTP proposed the establishment of the panel of consumers E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Page 32963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0684]


Identification of Alternative In Vitro Bioequivalence Pathways 
Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance 
and Quality of Non-Systemically Absorbed Drug Products for Animals; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period related to the use of in vitro methods as a mechanism 
for assessing the in vivo product bioequivalence (BE) of 
nonsystemically absorbed drug products intended for use in veterinary 
species, published in the Federal Register of March 18, 2015 (80 FR 
14146). FDA is reopening the comment period to update comments and to 
receive any new information.

DATES: Submit either electronic or written comments by August 10, 2015.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John Harshman, Center for Veterinary 
Medicine, Food and Drug Administration, HFV-170, MPN2, 7500 Standish 
Pl., Rockville, MD 20855, 240-402-0845.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 18, 2015 (80 FR 14146), FDA 
announced a public meeting to discuss the use of in vitro methods as a 
mechanism for assessing the in vivo product bioequivalence (BE) of 
nonsystemically absorbed drug products intended for use in veterinary 
species. In the same notice, FDA said that it is seeking additional 
public comment to the docket. Interested persons were originally given 
until May 18, 2015, to comment on this issue.

II. Request for Comments

    Following publication of the March 18, 2015, notification of public 
meeting and request for comments, FDA received a request to allow 
interested persons additional time to comment. The requester asserted 
that the time period of 60 days was insufficient to respond fully to 
FDA's specific requests for comments and to allow potential respondents 
to thoroughly evaluate and address pertinent issues.

III. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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.

    Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14101 Filed 6-9-15; 8:45 am]
 BILLING CODE 4164-01-P
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