Agency Information Collection Activities; Proposed Collection; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine, 16021-16022 [E8-6065]

Download as PDF 16021 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices manufacturer or distributor of a dietary supplement containing a new dietary ingredient, or of a new dietary ingredient, to submit to the Office of Nutrition, Labeling, and Dietary Supplements notification of the basis for their conclusion that said supplement or ingredient will reasonably be expected to be safe. Section 190.6(b) requires that the notification include the following: (1) The complete name and address of the manufacturer or distributor, (2) the name of the new dietary ingredient, (3) a description of the dietary supplements that contain the new dietary ingredient, and (4) the history of use or other evidence of safety establishing that the dietary ingredient will reasonably be expected to be safe. The notification requirements described previously are designed to enable FDA to monitor the introduction into the food supply of new dietary ingredients and dietary supplements that contain new dietary ingredients, in order to protect consumers from unsafe dietary supplements. FDA uses the information collected under these regulations to help ensure that a manufacturer or distributor of a dietary supplement containing a new dietary ingredient is in full compliance with the act. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 190.6 1 There 71 Total Annual Responses 1 Hours per Response 71 Total Hours 20 1,420 are no capital costs or operating and maintenance costs associated with this collection of information. The agency believes that there will be minimal burden on the industry to generate data to meet the requirements of the premarket notification program because the agency is requesting only that information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing a new dietary ingredient is in full compliance with the act. However, the agency estimates that extracting and summarizing the relevant information from the company’s files and presenting it in a format that will meet the requirements of section 413 of the act will require a burden of approximately 20 hours of work per submission. The estimated number of premarket notifications and hours per response is an average based on the agency’s experience with notifications received during the last 3 years (i.e., 2005, 2006, and 2007), and information from firms that have submitted recent premarket notifications. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. pwalker on PROD1PC71 with NOTICES Annual Frequency per Response Dated: March 19, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–6061 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 18:52 Mar 25, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0173] Agency Information Collection Activities; Proposed Collection; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine 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 on the information collection requirements for appeals of science-based decisions above the division level at the Center for Veterinary Medicine (CVM). DATES: Submit written or electronic comments on the collection of information by May 27, 2008. ADDRESSES: Submit electronic comments on the collection of information to http:// 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\26MRN1.SGM 26MRN1 16022 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices 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. Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine—21 CFR Part 10.75 (OMB Control Number 0910– 0566)—Extension CVM’s ‘‘Guidance for Industry #79— Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine’’ describes the process by which CVM formally resolves disputes relating to scientific controversies. A scientific controversy involves issues concerning a specific product regulated by CVM related to matters of technical expertise and requires specialized education, training, or experience to be understood and resolved. Further, the guidance details information on how the agency intends to interpret and apply provisions of the existing regulations regarding internal agency review of decisions. In addition, the guidance outlines the established recommended procedures for persons who are applicants, including sponsor applicants or manufacturers, for animal drugs or other products regulated by CVM, that wish to submit a request for review of a scientific dispute. When an applicant has a scientific disagreement and a written decision by CVM, the applicant may submit a request for review of that decision by following the established agency channels of supervision for review. Respondents to this collection of information are applicants that wish to submit a request for review of a scientific dispute. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 10.75 2 1There Dated: March 18, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–6065 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting pwalker on PROD1PC71 with NOTICES Total Annual Responses 4 Hours per Response 8 Total Hours 10 80 are no capital costs or operating and maintenance costs associated with this collection of information. This estimated annual reporting burden is based on CVM’s experience over the past 3 years in handling formal appeals for scientific disputes. The number of respondents multiplied by the annual frequency of response equals the total annual responses. The number of hours per response is based on discussions with industry and may vary depending on the complexity of the issue(s) involved and the duration of the appeal process. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. AGENCY: Food and Drug Administration, HHS. ACTION: Annual Frequency per Response Notice. This notice announces a forthcoming meeting of a public advisory committee VerDate Aug<31>2005 18:52 Mar 25, 2008 Jkt 214001 of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anesthetic and Life Support Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on May 7, 2008, from 8 a.m. to 4:30 p.m. Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD, 301–948–8900. Contact Person: Teresa Watkins, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 301– 827–7001, FAX: 301–827–6776, e-mail: Teresa.Watkins@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572) in Washington, DC area), code 3014512529. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On May 7, 2008, the committee will discuss new drug PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 application (NDA) 22–244, fospropofol disodium injection (35 milligrams/ milliliter) (proposed tradename Aquavan), MGI Pharma, Inc., for the proposed indication of sedation in adult patients undergoing diagnostic or therapeutic procedures. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 23, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 15, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Pages 16021-16022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0173]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Appeals of Science-Based Decisions Above the Division 
Level at the Center for Veterinary Medicine

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 on the information collection 
requirements for appeals of science-based decisions above the division 
level at the Center for Veterinary Medicine (CVM).

DATES: Submit written or electronic comments on the collection of 
information by May 27, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 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

[[Page 16022]]

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.

Appeals of Science-Based Decisions Above the Division Level at the 
Center for Veterinary Medicine--21 CFR Part 10.75 (OMB Control Number 
0910-0566)--Extension

    CVM's ``Guidance for Industry 79--Dispute Resolution 
Procedures for Science-Based Decisions on Products Regulated by the 
Center for Veterinary Medicine'' describes the process by which CVM 
formally resolves disputes relating to scientific controversies. A 
scientific controversy involves issues concerning a specific product 
regulated by CVM related to matters of technical expertise and requires 
specialized education, training, or experience to be understood and 
resolved. Further, the guidance details information on how the agency 
intends to interpret and apply provisions of the existing regulations 
regarding internal agency review of decisions. In addition, the 
guidance outlines the established recommended procedures for persons 
who are applicants, including sponsor applicants or manufacturers, for 
animal drugs or other products regulated by CVM, that wish to submit a 
request for review of a scientific dispute. When an applicant has a 
scientific disagreement and a written decision by CVM, the applicant 
may submit a request for review of that decision by following the 
established agency channels of supervision for review.
    Respondents to this collection of information are applicants that 
wish to submit a request for review of a scientific dispute.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75                                                                   2                     4                  8                 10                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimated annual reporting burden is based on CVM's experience 
over the past 3 years in handling formal appeals for scientific 
disputes. The number of respondents multiplied by the annual frequency 
of response equals the total annual responses. The number of hours per 
response is based on discussions with industry and may vary depending 
on the complexity of the issue(s) involved and the duration of the 
appeal process.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

    Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6065 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S