Guideline No. 66
Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE
ESTIMATED STATE MEDIAN INCOME FOR 4-PERSON FAMILIES, BY STATE, FEDERAL FISCAL YEAR 20031 1—Continued
|
States |
Estimated state median income 4- person families 2 |
60 percent of estimatedstate median income 4-person families |
|
Ohio |
62,251 |
37,351 |
|
Oklahoma |
48,459 |
29,075 |
| Oregon |
58,315 |
34,989 |
|
Pennsylvania |
65,411 |
39,247 |
|
Rhode Island |
68,418 |
41,051 |
|
South Carolina |
56,294 |
33,776 |
|
South Dakota |
55,150 |
33,090 |
|
Tennessee |
54,899 |
32,939 |
|
Texas |
53,513 |
32,108 |
|
Utah |
57,043 |
34,226 |
|
Vermont |
59,125 |
35,475 |
|
Virginia |
68,054 |
40,832 |
|
Washington |
63,568 |
38,141 |
|
West Virginia |
46,270 |
27,762 |
|
Wisconsin |
66,725 |
40,035 |
|
Wyoming |
55,859 |
33,515 |
Note: FFY 2003 covers the period of October 1, 2002 through September 30, 2003. The estimated median income for 4-person families living in the United States is $62,228 for FFY 2003. The estimates are effective for the Low Income Home Energy Assistance Program (LIHEAP) at any time between the date of this publication and October 1, 2002, or by the beginning of a LIHEAP grantee’s fiscal year, whichever is later.
1) In accordance with 45 CFR 96.85, each State’s estimated median income for a 4-person family is multiplied by the following percentages to adjust for family size: 52% for one person, 68% for two persons, 84% for three persons, 100% for four persons, 116% for five persons, and 132% for six persons. For family sizes greater than six persons, add 3% for each additional family member and multiply the new percentage by the State’s estimated median income for a 4-person family.
2) Prepared by the Bureau of the Census from the March 2001 Current Population Survey, 1990 Decennial Census of Population and Housing, and 2000 per capita personal income estimates, by state, from the Bureau of Economic Analysis (BEA). In 1999, BEA revised its methodology in estimating per capita personal income estimates. BEA’s revised methodology is reflected in the FFY 2003 state 4-person family median income estimates. For further information, contact the Housing and Household Economic Statistics Division at the Bureau of the Census (301–457– 3243).
[FR Doc. 02
–2224 Filed 1–29–02; 8:45 am]
DEPARTMENT OF HEALTH AND
Food and Drug Administration [Docket No. 98D–0016]
Withdrawal of Guidance Document on Professional Flexible Labeling of
AGENCY
SUMMARY: The Food and Drug Administration (FDA) is withdrawing a guidance for industry (#66) entitled ‘‘Professional Flexible Labeling of Antimicrobial Drugs.’’ This guidance, which was issued in August 1998, is being withdrawn because it does not represent current agency thinking on the development of professional flexible labeling for therapeutic veterinary prescription antimicrobial drugs. The agency intends to develop a new document on this topic. DATES: Submit written or electronic comments at any time. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 061, Rockville, MD 20852. Submit lectronic comments to http://ww.fda.gov/dockets/ecomments. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Andrew J. Beaulieu, Center for Veterinary Medicine (HFV–1), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20851, 301–827–2954.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is withdrawing a guidance for industry (#66) entitled ‘‘Professional Flexible Labeling of Antimicrobial Drugs.’’ This guidance addresses the development of professional flexible labeling for prescription therapeutic antimicrobial new animal drugs. This guidance is being withdrawn because the agency now believes that the ‘‘broad indication’’ that was described in the guidance, particularly the very broad indication used as an example, is not consistent with the kind of database that typically can be generated to support an antimicrobial new animal drug approval. In the Federal Register of July 28, 1999 (64 FR 40746), the agency revised its definition of ‘‘substantial evidence’’ in the animal drug regulations (21 CFR 514.4). In light of that definition and experience regarding the manner in which products are being advertised or otherwise promoted for use under the broad indication ’’ provision of the guidance, FDA is withdrawing this guidance. The guidance no longer reflects the agencys current thinking on how sponsors can provide substantial evidence of effectiveness for all of the conditions that could fall within a broad (or collective’’) indication on the label of a prescription therapeutic antimicrobial new animal drug.
The agency intends to develop a new guidance on this issue and will publish it as a level 1 draft guidance in accordance with the agencys good guidance practices in 21 CFR 10.115. The focus of the revisions will be the Indications and Microbiology sections of the guidance. The guidance revisions will more clearly set out the basis for the substantial evidence of effectiveness. In the interim, sponsors of antimicrobial products should consult with the Center for Veterinary Medicine (CVM) at FDA for more detailed information regarding acceptable content for the sections of the labeling. In general, CVM encourages sponsors to discuss all aspects of product development through presubmission conferences and other meetings with CVM.
II. Significance of Guidance
This information is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
III. Comments
The agency welcomes comments on its efforts to review existing guidances related to the development of new animal drug products and revise, reformat, or withdraw them, as appropriate. P>Interested persons may submit written or electronic comments on agency guidance documents to the Dockets Management Branch (address above) at any time. Two copies of any written comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of received comments is available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02–2212 Filed 1–29–02; 8:45 am]
BILLING CODE 4160–01-S
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, (Public Law 92–463), announcement is made of the following National Advisory Committee scheduled to meet during the month of February 2002.
Name: Advisory Committee on Interdisciplinary, Community-Based
Linkages.
Date and Time: February 4, 2002; 8 a.m.–5 p.m.; February 5, 2002; 8 a.m.–5 p.m.; February 6, 2002; 8 a.m.–1 p.m.Place: The Doubletree Hotel, Rockville, Maryland, 1750 Rockville Pike, Rockville, Maryland 20852.
The meeting is open to the public. Agenda items will include, but not be limited to: Welcome; introduction of the Division of State, Community and Public Health Staff; members reactions to the inaugural report submitted to the Secretary of Health and Human Services, November 2001; Federal staff reactions to report; and plenary discussion of Committee goals for 2002– 2003; ongoing guidance provided on an adhoc basis by Federal program staff from the Division of State, Community and Public Health; general discussion among Committee embers of its charge under Section 756 of the Public Health Service Act, to include iscussion of Committee reports; scheduling of the next Committee meeting, which shall include but not be limited to: General iscussion of topics to be addressed during he next Committee meeting.
Public comment will be permitted before lunch and at the end of the Committee meeting on February 4, 2002. Oral resentations will be limited to 5 minutes per public speaker. Persons interested in providing an oral presentation should submit written request, with a copy of their resentation to: Mrs. Tempie Desai, Principal staff Liaison, Division of State, Community and Public Health, Bureau of Health Professions, Health Resources and Services Administration, Room 9–105, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone 301) 443-0132
.
Requests should contain the name, address, telephone number, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The Division of State, Community and Public Health will notify each presenter by mail or telephone of their assigned presentation time.
Persons who do not file an advance request for a presentation, but wish to make an oral statement may register to do so at the Doubletree Hotel, Rockville, Maryland, on February 4, 2002. These persons will be allocated time as the Committee meeting agenda permits.
Anyone requiring information regarding the Committee should contact Mrs. Tempie Desai, Division of State, Community and Public Health, Bureau of Health Professions, Health Resources and Services Administration, Room 9–105, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone (301) 443–0132
Proposed agenda items are subject to change as priorities dictate.
Dated: January 25, 2002.
Jane M. Harrison,
Director, Division of Policy Review and Coordination.
[FR Doc. 02–2269 Filed 1–25–02; 4:37 pm] BILLING CODE 4165–15–P
[Docket No. FR–4734–N–02]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
Notice of Submission of Proposed
Information Collection to OMB; HOME
Investment Partnerships Program
AGENCY: Office of the Chief Information Officer, HUD.
ACTION: Notice
SUMMARY:
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
DATES: Comments Due Date: March 1, 2002.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval number (2506–0171) should be sent to: Joseph F. Lackey, Jr., OMB Desk Officer, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Wayne Eddins, Reports Management Officer, Q, Department of Housing and Urban Development, 451 Seventh Street, Southwest, Washington, DC 20410; email Wayne_Eddins@HUD.gov; telephone(202) 708–2374. This is not a toll-free number. Copies of the proposed forms and other available documents submitted to OMB may be obtained from Mr. Eddins.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.
Title of Proposal: HOME Investment Partnerships Program.
This Notice also lists the following
information:
OMB Approval Number: 2506–0171.
Form Numbers: HUD–40093, HUD–40093A, HUD–40107 and HUD–40107A.
Description of the Need for the Informaiton and its Proposed Use: The
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