Agency Information Collection Activities: Proposed Collection: Comment Request, 54447-54448 [E7-18911]

Download as PDF Federal Register / Vol. 72, No. 185 / Tuesday, September 25, 2007 / Notices yshivers on PROD1PC62 with NOTICES Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740– 3835, 301–436–1071. SUPPLEMENTARY INFORMATION: I. Background The Food and Drug Administration (FDA) is responsible for prescribing the conditions of safe use of food additives under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348). To evaluate the safety of food additives and determine their conditions of safe use, the agency uses various premarket approval processes (food additive petition process (21 CFR 171.1), premarket notification process for food contact substances (21 CFR 170.100), and threshold of regulation process for substances used in food contact articles that migrate or may be expected to migrate into food (21 CFR 170.39)). This guidance provides answers to common questions arising during the preparation of premarket submissions that seek FDA approval of new antimicrobial food additives. This guidance will assist petitioners and notifiers in designing studies to determine whether an antimicrobial food additive achieves its intended technical effect. In addition, this guidance discusses microbiological data that may demonstrate that an antimicrobial agent will be safe for the intended use. This guidance applies to all premarket approval submissions for food additives that are intended to control microbes in or on food, including sources of radiation for treating food. The agency has adopted good guidance practices (GGPs) that set forth the agency’s policies and procedures for the development, issuance, and use of guidance documents (21 CFR 10.115). This draft guidance is being issued as a Level 1 guidance document consistent with the GGPs. The draft guidance represents the agency’s current thinking on microbiological considerations for antimicrobial food additive VerDate Aug<31>2005 15:20 Sep 24, 2007 Jkt 211001 submissions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT). II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 70.25, 71.1, 170.35, and 171.1 have been approved under OMB control number 0910–0016; the collection of information in 21 CFR 170.39 has been approved under OMB control number 0190–0298; and the collections of information in 21 CFR 170.101 and 170.106 have been approved under OMB control number 0190–0495. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. If you base your comments on scientific evidence or data, please submit copies of the specific information along with your comments. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at http:// www.cfsan.fda.gov/guidance.html. Dated: September 18, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–18816 Filed 9–24–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 54447 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443–1129. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: The Division of Independent Review Grant Reviewer Recruitment Form (OMB No. 0915– 0295): Extension HRSA’s Division of Independent Review (DIR) is responsible for carrying out the independent and objective review of all eligible applications submitted to HRSA. DIR ensures that the independent review process is efficient, effective, economical, and complies with statutes, regulations, and policies. The review of applications is performed by people knowledgeable in the field of endeavor for which support is requested and is advisory to individuals in HRSA responsible for making award decisions. To streamline the selection and assignment of grant reviewers to objective review committees, HRSA utilizes a Web-based data collection form to gather critical reviewer information. The Grant Reviewer Form standardizes pertinent categories of reviewer information, such as: Areas of E:\FR\FM\25SEN1.SGM 25SEN1 54448 Federal Register / Vol. 72, No. 185 / Tuesday, September 25, 2007 / Notices expertise; occupations; work settings; reviewer experience; and allows maximum use of drop-down menus to simplify the data collection process. The Web-based system also permits reviewers to update their information as needed. HRSA maintains a pool of approximately 5,000 individuals that Responses per respondent Number of respondents Grant recruitment form have previously served on HRSA objective review committees. The estimated annual burden is as follows: Total responses Hours per response (min.) Total burden hours New reviewer ....................................................................... Updating reviewer information ............................................. 1,200 3,700 1 1 1,200 3,700 45 30 900 1,850 Total .............................................................................. 4,900 ........................ 4,900 ........................ 2,750 Send comments to Susan G. Queen, PhD., HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: September 19, 2007. Alexandra Huttinger, Acting Director, Director, Division of Policy Review and Coordination. [FR Doc. E7–18911 Filed 9–24–07; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [COTP New Orleans 07–019] Area Maritime Security Committee, New Orleans; Vacancies Positions Available on the Committee Coast Guard, DHS. Request for applications. AGENCY: yshivers on PROD1PC62 with NOTICES ACTION: SUMMARY: The Coast Guard seeks applications for membership in the Area Maritime Security Committee, New Orleans. The Committee assists the Captain of the Port, New Orleans, in developing, reviewing, and updating the Area Maritime Security Plan for their area of responsibility. DATES: Requests for membership should reach the Captain of the Port, New Orleans, on October 25, 2007. ADDRESSES: Submit applications for membership to the Captain of the Port, New Orleans, Attn: Planning Department, 201 Hammond Hwy., Metairie, La. 70005. FOR FURTHER INFORMATION CONTACT: Mr. Roy Ford at 504–565–5092 or Mr. James Nolan 504–565–5085. SUPPLEMENTARY INFORMATION: The Committee The Area Maritime Security Committee, New Orleans (the Committee), is established under, and VerDate Aug<31>2005 15:20 Sep 24, 2007 Jkt 211001 governed by, 33 CFR part 103, subpart C. The functions of the Committee include, but are not limited to, the following: (1) Identifying critical port infrastructure and operations. (2) Identifying risks (i.e., threats, vulnerabilities, and consequences). (3) Determining strategies and implementation methods for mitigation. (4) Developing and describing the process for continuously evaluating overall port security by considering consequences and vulnerabilities, how they may change over time, and what additional mitigation strategies can be applied. (5) Advising and assisting the Captain of the Port in developing, reviewing, and updating the Area Maritime Security Plan under 33 CFR part 103, subpart E. There are 8 vacancies on the Committee. Members may be selected from— (1) The Federal, Territorial, or Tribal government; (2) The State government and political subdivisions of the State; (3) Local public safety, crisis management, and emergency response agencies; (4) Law enforcement and security organizations; (5) Maritime industry, including labor; (6) Other port stakeholders having a special competence in maritime security; and (7) Port stakeholders affected by security practices and policies. In support of the Coast Guard’s policy on gender and ethnic diversity, we encourage qualified women and members of minority groups to apply. background check before appointment to the Committee. The term of office for each vacancy is 5 years. However, a member may serve one additional term of office. Members are not salaried or otherwise compensated for their service on the Committee. Format of Applications Applications for membership may be in any format. However, because members must demonstrate an interest in the security of the area covered by the Committee, we particularly encourage the submission of information highlighting experience in maritime or security matters. Authority Section 102 of the Maritime Transportation Security Act of 2002 (Pub. L. 107–295) (the Act) authorizes the Secretary of the Department in which the Coast Guard is operating to establish Area Maritime Security Committees for any port area of the United States. See 33 U.S.C. 1226; 46 U.S.C. 70112(a)(2); 33 CFR 103.205; Department of Homeland Security Delegation No. 0170.1. The Act exempts Area Maritime Security Committees from the Federal Advisory Committee Act (FACA), 5 U.S.C. App. (Pub. L. 92– 463). Dated: August 31, 2007. L.D. Stroh, Captain, U.S. Coast Guard, Captain of the Port, New Orleans. [FR Doc. E7–18886 Filed 9–24–07; 8:45 am] BILLING CODE 4910–15–P Qualification of Members Members must have at least 5 years of experience related to maritime or port security operations. Applicants may be required to pass an appropriate security PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1

Agencies

[Federal Register Volume 72, Number 185 (Tuesday, September 25, 2007)]
[Notices]
[Pages 54447-54448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18911]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and draft instruments, call the HRSA Reports Clearance 
Officer on (301) 443-1129.
    Comments are invited on: (a) The proposed collection of information 
for the proper performance of the functions of the agency; (b) the 
accuracy of the agency's estimate of the burden of the proposed 
collection of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: The Division of Independent Review Grant Reviewer 
Recruitment Form (OMB No. 0915-0295): Extension

    HRSA's Division of Independent Review (DIR) is responsible for 
carrying out the independent and objective review of all eligible 
applications submitted to HRSA. DIR ensures that the independent review 
process is efficient, effective, economical, and complies with 
statutes, regulations, and policies. The review of applications is 
performed by people knowledgeable in the field of endeavor for which 
support is requested and is advisory to individuals in HRSA responsible 
for making award decisions.
    To streamline the selection and assignment of grant reviewers to 
objective review committees, HRSA utilizes a Web-based data collection 
form to gather critical reviewer information. The Grant Reviewer Form 
standardizes pertinent categories of reviewer information, such as: 
Areas of

[[Page 54448]]

expertise; occupations; work settings; reviewer experience; and allows 
maximum use of drop-down menus to simplify the data collection process. 
The Web-based system also permits reviewers to update their information 
as needed. HRSA maintains a pool of approximately 5,000 individuals 
that have previously served on HRSA objective review committees.
    The estimated annual burden is as follows:

 
----------------------------------------------------------------------------------------------------------------
                                                                                     Hours per
     Grant recruitment form          Number of     Responses per       Total         response      Total burden
                                    respondents     respondent       responses        (min.)           hours
----------------------------------------------------------------------------------------------------------------
New reviewer....................           1,200               1           1,200              45             900
Updating reviewer information...           3,700               1           3,700              30           1,850
���������������������������������
    Total.......................           4,900  ..............           4,900  ..............           2,750
----------------------------------------------------------------------------------------------------------------

    Send comments to Susan G. Queen, PhD., HRSA Reports Clearance 
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857. Written comments should be received within 60 days of this 
notice.

    Dated: September 19, 2007.
Alexandra Huttinger,
Acting Director, Director, Division of Policy Review and Coordination.
 [FR Doc. E7-18911 Filed 9-24-07; 8:45 am]
BILLING CODE 4165-15-P