Request for Nominations for Nonvoting Member Representing Industry Interests on a Public Advisory Committee; Nonprescription Drugs Advisory Committee, 69345-69346 [05-22562]

Download as PDF Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Notices amount of soy protein in foods that contain soy as the sole source of protein. However, at the present time there is no validated analytical methodology available to quantify the amount of soy protein in foods that contain other sources of protein. For these latter foods, FDA must rely on information known only to the manufacturer to assess compliance with the requirement that the food contain the qualifying amount of soy protein. Thus, FDA requires manufacturers to have and keep records to substantiate the amount of soy protein in a food that bears the health claim and contains sources of protein other than soy, and to make such records available to appropriate regulatory officials upon written request. The information collected includes nutrient data bases or analyses, recipes or formulations, purchase orders for ingredients, or any other information 69345 that reasonably substantiates the ratio of soy protein to total protein. In the Federal Register of August 23, 2005 (70 FR 49295), FDA published a 60-day notice requesting public comment on the information collection provisions. One comment was received that was not related to the information collection. FDA estimates the burden of the collection of information as follows: TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR section Number of respondents 101.82(c)(2)(ii)(B) 1 There Annual frequency per response 25 Total annual responses 1 Dated: November 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–22636 Filed 11–14–05; 8:45 am] BILLING CODE 4160–01–S 1 25 25 FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. 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 0910–0574. The approval expires on April 30, 2006. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. SUPPLEMENTARY INFORMATION: Dated: November 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–22637 Filed 11–14–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. 2005N–0424] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey on Program Funding Food and Drug Administration, HHS. ACTION: Total hours are no capital costs or operating and maintenance costs associated with this collection of information. Based upon its experience with the use of health claims, FDA estimates that only about 25 firms would be likely to market products bearing a soy protein/ coronary heart disease health claim and that only, perhaps, one of each firm’s products might contain nonsoy sources of protein along with soy protein. The records required to be retained by § 101.82(c)(2)(ii)(B) are the records, e.g., the formulation or recipe, that a manufacturer has and maintains as a normal course of its doing business. Thus, the burden to the food manufacturer is that involved in assembling and providing the records to appropriate regulatory officials for review or copying. AGENCY: Hours per response Request for Nominations for Nonvoting Member Representing Industry Interests on a Public Advisory Committee; Nonprescription Drugs Advisory Committee AGENCY: Food and Drug Administration, HHS. Notice. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Survey on Program Funding’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Notice. SUMMARY: VerDate Aug<31>2005 15:50 Nov 14, 2005 Jkt 208001 SUMMARY: The Food and Drug Administration (FDA) is requesting nominations for a nonvoting industry representative to serve on the Nonprescription Drugs Advisory Committee. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 All letters of interest and nominations should be received on or before December 15, 2005. ADDRESSES: Letters of intent and nominations for membership should be submitted to Jayne Peterson (see FOR FURTHER INFORMATION CONTACT). FOR FURTHER INFORMATION CONTACT: Jayne Peterson, Advisors and Consultants Staff (HFD–21), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, e-mail: petersonj@cder.fda.gov. SUPPLEMENTARY INFORMATION: The agency requests nominations for a nonvoting industry representative to serve on the Nonprescription Drugs Advisory Committee. DATES: I. Function The function of the committee is to review and evaluate available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products for use in the treatment of a broad spectrum of human symptoms and diseases. II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this notice. Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested E:\FR\FM\15NON1.SGM 15NON1 69346 Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Notices organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for a particular committee. If no individual is selected within 60 days, the Commissioner of Food and Drugs will select the nonvoting member to represent industry interests. III. Application Procedure Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for that committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.) FDA has a special interest in ensuring that women, minority groups, individuals with physical disabilities, and small businesses are adequately represented on its advisory committees, and therefore, encourages nominations for appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from drug manufacturing industry. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app 2) and 21 CFR part 14, relating to advisory committees. Dated: November 4, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. 05–22562 Filed 11–14–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2005–22878] Collection of Information Under Review by Office of Management and Budget (OMB): OMB Control Numbers: 1625–0022, 1625–0079, 1625–0088, 1625–0093, and 1625–0094. Coast Guard, DHS. Request for comments. AGENCY: ACTION: SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to seek the VerDate Aug<31>2005 15:50 Nov 14, 2005 Jkt 208001 approval of OMB for the renewal of five Information Collection Requests (ICRs). The ICRs are: (1) 1625–0022, Application for Tonnage Measurement of Vessels; (2) 1625–0079, Standards of Training, Certification and Watchkeeping for Seafarers (STCW), 1995 and 1997 Amendments to the International Convention; (3)1625–0088, Voyage Planning for Tank Barge Transits in the Northeast United States; (4) 1625–0093, Facilities Transferring Oil or Hazardous Materials in Bulk— Letter of Intent and Operations Manual; and (5) 1625–0094, Ships Carrying Bulk Hazardous Liquids. Before submitting the ICRs to OMB, the Coast Guard is inviting comments on them as described below. DATES: Comments must reach the Coast Guard on or before January 17, 2006. ADDRESSES: To make sure that your comments and related material do not enter the docket [USCG–2005–22878] more than once, please submit them by only one of the following means: (1) By mail to the Docket Management Facility, U.S. Department of Transportation (DOT), room PL–401, 400 Seventh Street SW, Washington, DC 20590–0001. (2) By delivery to room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street SW, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202–366– 9329. (3) By fax to the Docket Management Facility at 202–493–2251. (4) Electronically through the Web Site for the Docket Management System at https://dms.dot.gov. The Docket Management Facility maintains the public docket for this notice. Comments and material received from the public, as well as documents mentioned in this notice as being available in the docket, will become part of this docket and will be available for inspection or copying at room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet at https://dms.dot.gov. Copies of the complete ICRs are available through this docket on the Internet at https://dms.dot.gov, and also from Commandant (CG–611), U.S. Coast Guard Headquarters, room 6106 (Attn: Mr. Arthur Requina), 2100 Second Street SW., Washington, DC 20593– 0001. The telephone number is 202– 267–2326. FOR FURTHER INFORMATION CONTACT: Mr. Arthur Requina, Office of Information PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Management, telephone 202–267–2326, or fax 202–267–4814, for questions on these documents; or telephone Ms. Renee V. Wright, Program Manager, Docket Operations, 202–493–0402, for questions on the docket. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments We encourage you to respond to this request for comments by submitting comments and related materials. We will post all comments received, without change, to https://dms.dot.gov; they will include any personal information you have provided. We have an agreement with DOT to use the Docket Management Facility. Please see the paragraph on DOT’s ‘‘Privacy Act Policy’’ below. Submitting comments: If you submit a comment, please include your name and address, identify the docket number [USCG–2005–22878], indicate the specific section of the document to which each comment applies, and give the reason for each comment. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES; but please submit them by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 81⁄2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change the documents supporting this collection of information or even the underlying requirements in view of them. Viewing comments and documents: To view comments, as well as documents mentioned in this notice as being available in the docket, go to https://dms.dot.gov at any time and conduct a simple search using the docket number. You may also visit the Docket Management Facility in room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Privacy Act: Anyone can search the electronic form of all comments received in dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Privacy Act Statement of DOT in the Federal Register published on April 11, E:\FR\FM\15NON1.SGM 15NON1

Agencies

[Federal Register Volume 70, Number 219 (Tuesday, November 15, 2005)]
[Notices]
[Pages 69345-69346]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Nonvoting Member Representing 
Industry Interests on a Public Advisory Committee; Nonprescription 
Drugs Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for a nonvoting industry representative to serve on the 
Nonprescription Drugs Advisory Committee.

DATES: All letters of interest and nominations should be received on or 
before December 15, 2005.

ADDRESSES: Letters of intent and nominations for membership should be 
submitted to Jayne Peterson (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Jayne Peterson, Advisors and 
Consultants Staff (HFD-21), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane (for express delivery, 
5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, e-
mail: petersonj@cder.fda.gov.

SUPPLEMENTARY INFORMATION: The agency requests nominations for a 
nonvoting industry representative to serve on the Nonprescription Drugs 
Advisory Committee.

I. Function

    The function of the committee is to review and evaluate available 
data concerning the safety and effectiveness of over-the-counter 
(nonprescription) human drug products for use in the treatment of a 
broad spectrum of human symptoms and diseases.

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this notice. Within the subsequent 30 days, FDA will send a letter to 
each organization that has expressed an interest, attaching a complete 
list of all such organizations; and a list of all nominees along with 
their current resumes. The letter will also state that it is the 
responsibility of the interested

[[Page 69346]]

organizations to confer with one another and to select a candidate, 
within 60 days after the receipt of the FDA letter, to serve as the 
nonvoting member to represent industry interests for a particular 
committee. If no individual is selected within 60 days, the 
Commissioner of Food and Drugs will select the nonvoting member to 
represent industry interests.

III. Application Procedure

    Individuals may self nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. A current curriculum vitae and the name of the 
committee of interest should be sent to the FDA contact person. FDA 
will forward all nominations to the organizations expressing interest 
in participating in the selection process for that committee. (Persons 
who nominate themselves as nonvoting industry representatives will not 
participate in the selection process.)
    FDA has a special interest in ensuring that women, minority groups, 
individuals with physical disabilities, and small businesses are 
adequately represented on its advisory committees, and therefore, 
encourages nominations for appropriately qualified candidates from 
these groups. Specifically, in this document, nominations for nonvoting 
representatives of industry interests are encouraged from drug 
manufacturing industry.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app 2) and 21 CFR part 14, relating to advisory committees.

    Dated: November 4, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-22562 Filed 11-14-05; 8:45 am]
BILLING CODE 4160-01-S

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