71420 Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Notices 

submissions may be made to the contact 

person by January 6, 2005. Oral 

presentations from the public will be 

scheduled between approximately 8:15 

a.m. and 9:30 a.m. on January 14, 2005. 

Time allotted for each presentation may 

be limited. Those desiring to make 

formal oral presentations should notify 

the contact person before January 6, 

2005, 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. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact LaNise Giles 

at least 7 days in advance of the 

meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: December 1, 2004. 

Sheila Dearybury Walcoff, 

Associate Commissioner for External 

Relations.

[FR Doc. 04–26995 Filed 12–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0327] 

Draft Compliance Guidance for Small 

Business Entities on Labeling Overthe-Counter Human Drug Products; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft compliance 

guidance for small business entities 

entitled ‘‘Labeling OTC Human Drug 

Products; Small Entity Compliance 

Guide.’’ FDA has prepared this guidance 

in accordance with the Small Business 

Regulatory Enforcement Fairness Act. It 

is intended to help small businesses 

better understand the new over-thecounter (OTC) labeling requirements 

and to prepare new labeling within the 

prescribed implementation compliance 

dates.

DATES: Submit written or electronic 

comments on the draft compliance 

guidance by February 7, 2005. General 

comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft compliance 

guidance to the Division of Drug 

Information (HFD–240), Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit written comments on the draft 

compliance 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 

compliance guidance document.

FOR FURTHER INFORMATION CONTACT:

Cazemiro R. Martin or Gerald M. 

Rachanow, Center for Drug Evaluation 

and Research (HFD–560), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

2222.

SUPPLEMENTARY INFORMATION: FDA is 

announcing the availability of a draft 

compliance guidance for small business 

entities entitled ‘‘Labeling OTC Human 

Drug Products; Small Entity Compliance 

Guide.’’ FDA has prepared this guidance 

in accordance with section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act. This is one of several 

guidances the agency is developing to 

help manufacturers, packers, and 

distributors implement the final rule 

establishing standardized content and 

format requirements for the labeling of 

all OTC drug products. Once finalized, 

these guidances will supersede all other 

statements, feedback, and 

correspondence provided by the agency 

on these matters since the issuance of 

the final rule. 

In the Federal Register of March 17, 

1999 (64 FR 13254), FDA published a 

final rule establishing standardized 

content and format regulations for the 

labeling of OTC drug products. This 

regulation is intended to standardize 

labeling for all OTC drug products so 

consumers can easily read and 

understand OTC drug product labeling 

and use these products safely and 

effectively. 

The regulation for this new 

standardized labeling requires 

manufacturers to present OTC drug 

labeling information in a prescribed 

order and format. The new format will 

require revision of all existing labeling 

and covers all OTC drug and drugcosmetic products, whether marketed 

under a new drug marketing application 

(NDA), abbreviated new drug 

application (ANDA), or OTC drug 

monograph (or product not yet the 

subject of a final OTC drug monograph). 

To reduce the economic impact on 

small business entities, the new 

regulations provide an additional 1-year 

period to comply with § 201.66 (21 CFR 

201.66) for OTC drug products with 

sales of less than $25,000 per year. You 

can find a copy of § 201.66 at the 

Division of Dockets Management Web 

site at http://www.fda.gov/cder/otc/

label/label-fr-reg.htm. 

Following issuance of the final rule, 

the agency received a number of 

inquires from manufacturers seeking 

guidance on how to present the labeling 

information for their OTC drug products 

using the new standardized content and 

format requirements. This draft 

guidance summarizes the new Drug 

Facts labeling requirements as set forth 

in § 201.66. The draft guidance also 

describes how to list those inactive 

ingredients that are different when a 

finished OTC drug product is obtained 

from multiple suppliers. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices (21 CFR 10.115). The draft 

compliance guidance, when finalized, 

will represent the agency’s current 

thinking on how OTC drug monograph 

labeling finalized prior to or after the 

new requirements can be converted to 

the new OTC ‘‘Drug Facts’’ format 

labeling. 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. 

I. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft compliance 

guidance. Two copies of mailed 

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. The draft 

compliance guidance and received 

comments are available for public 

examination in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Notices 71421

II. Electronic Access 

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: December 1, 2004. 

Jeffrey Shuren, 

Assistant Commissioner for Policy.

[FR Doc. 04–26993 Filed 12–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–4903–N–98] 

Notice of Submission of Proposed 

Information Collection to OMB; 

Resident Services and Satisfaction 

Survey

AGENCY: Office of the Chief Information 

Officer.

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. 

This is a request for continued 

approval to collect the information 

related to a survey of residents of 

assisted housing and insured housing. 

HUD conducts this to measure resident 

satisfaction with living conditions. 

Public housing agencies are required to 

implement the survey.

DATES: Comments Due Date: January 10, 

2005.

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

approval Number (2507–0001) and 

should be sent to: HUD Desk Officer, 

Office of Management and Budget, New 

Executive Office Building, Washington, 

DC 20503; fax: (202) 395–6974.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management 

Officer, AYO, Department of Housing 

and Urban Development, 451 Seventh 

Street, SW., Washington, DC 20410; email Wayne_Eddins@HUD.gov; or 

Lillian Deitzer at 

Lillian_L_Deitzer@HUD.gov or 

telephone (202) 708–2374. This is not a 

toll-free number. Copies of available 

documents submitted to OMB may be 

obtained from Mr. Eddins or Ms. Deitzer 

and at HUD’s Web site at http://

www5.hud.gov:63001/po/i/icbts/

collectionsearch.cfm.

SUPPLEMENTARY INFORMATION: This 

Notice informs the public that the U.S. 

Department of Housing and Urban 

Development (HUD) has submitted to 

OMB a request for approval of the 

information collection described below. 

This Notice is soliciting comments from 

members of the public and affecting 

agencies concerning the proposed 

collection of information to: (1) Evaluate 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information; (3) Enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Minimize the burden of the collection of 

information on those who are to 

respond; including through the use of 

appropriate automated collection 

techniques or other forms of information 

technology, e.g., permitting electronic 

submission of responses. 

This Notice also lists the following 

information: 

Title of Proposal: Resident Service 

and Satisfaction Survey. 

OMB Approval Number: 2507–0001. 

Form Numbers: None. 

Description of the Need for the 

Information and Its Proposed Use: HUD 

conducts a resident survey of assisted 

and insured housing residents to 

measure resident satisfaction with living 

conditions. Public housing agencies are 

required to implement the survey. 

Frequency of Submission: Annually.

Potential respondents Annual responses x Hours per response = Burden hours 

Reporting Burden ...................................................................................... 595,797 216,979 0.3 64,021 

The total potential respondents 

include public housing agencies, 

multifamily housing owners, and 

residents. 

Total Estimated Burden Hours:

64,021. 

Status: Extension of a currently 

approved collection.

Authority: Section 3507 of the Paperwork 

Reduction Act of 1995, 44 U.S.C. 35, as 

amended.

Dated: December 2, 2004. 

Wayne Eddins, 

Departmental Reports Management Officer, 

Office of the Chief Information Officer.

[FR Doc. E4–3560 Filed 12–8–04; 8:45 am] 

BILLING CODE 4210–72–P

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–4837–D–54] 

Delegation of Authority Under Section 

42(d)(5)(C) of the Internal Revenue 

Code

AGENCY: Office of the Secretary, HUD.

ACTION: Notice.

SUMMARY: In this notice, the Secretary 

delegates to the Assistant Secretary for 

Policy Development and Research 

concurrent authority to carry out the 

duties and responsibilities authorized to 

the Secretary of HUD by Section 

42(d)(5)(C) of the Internal Revenue 

Code.

DATES: Effective Date: January 1, 2005.

FOR FURTHER INFORMATION CONTACT: Kurt 

G. Usowski, Associate Deputy Assistant 

Secretary for Economic Affairs, Office of 

Policy Development and Research, 

Room 8204, Department of Housing and 

Urban Development, 451 Seventh Street, 

SW., Washington, DC 20410–6000, 

telephone (202) 708–2770 (this is not a 

toll-free number), or email 

Kurt_G._Usowski@hud.gov. Persons 

with speech or hearing impairments 

may access this number through TTY by 

calling the Federal Information Relay 

Service at 800–877–8339.

SUPPLEMENTARY INFORMATION: Section 

42(d)(5)(C) of the Internal Revenue Code 

of 1986 (26 U.S.C. 42(d)(5)(C)) 

authorizes the Secretary of HUD to 

designate qualified census tracts and 

difficult development areas for the lowincome housing tax credit. Section 7(d) 

of the Department of Housing and Urban 

Development Act (42 U.S.C. 3535(d)) 

authorizes the Secretary to delegate this 

authority, and the Secretary delegates 

the authority as follows: