63158 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Notices 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency 

per Recordkeeper Total Annual Records Hours Per Recordkeeper Total Hours 

807.31 16,200 4 64,800 .50 32,400

Total Burden Hours 32,400

1The burdens are explained as follows:

The annual reporting burden hours to 

respondents for registering 

establishments and listing devices is 

estimated to be 9,450 hours, and 

recordkeeping burden hours for 

respondents is estimated to be 32,400 

hours. The estimates cited in the tables 

above are based primarily upon the 

annual FDA accomplishment report, 

which includes actual FDA registration 

and listing figures from fiscal year (FY) 

2003. These estimates are also based on 

FDA estimates of FY 2003 data from 

current systems, conversations with 

industry and trade association 

representatives, and from internal 

review of the documents referred to in 

the previous tables.

According to 21 CFR part 807, all 

owners/operators are required to list, 

and establishments and U.S. agents are 

required to register. Each owner/

operator has an average of two 

establishments, according to statistics 

gathered from FDA’s registration and 

listing database. The database has 

25,100 active establishments listed in it. 

Based on past experience, the agency 

anticipated that approximately 7,300 

registrations will be processed during 

the first year, and 3,100 thereafter. FDA 

anticipates reviewing 200 historical files 

annually.

Dated: October 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24192 Filed 10–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Neurological Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public.

Name of Committee: Neurological 

Devices Panel of the Medical Devices 

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 November 30, 2004, from 8 a.m. 

to 5 p.m.

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B, and C, 

620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Janet L. Scudiero, 

Center for Devices and Radiological 

Health (HFZ–410), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–594–1184, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512513. Please call the Information 

Line for up-to-date information on this 

meeting.

Agenda: The committee will discuss, 

make recommendations, and vote on 

premarket approval application for a 

device intended for use as an adjunct to 

sutured dural repair during cranial 

surgery to provide watertight closure. 

Background information for the topic, 

including the agenda and questions for 

the committee, will be available to the 

public 1 business day before the 

meeting on the Internet at http://

www.fda.gov/cdrh/panelmtg.html.

Procedure: On November 30, 2004, 

from 8:30 a.m. to 5 p.m., the meeting 

will be open to the public. 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 by November 9, 2004. Oral 

presentations from the public will be 

scheduled for approximately 30 minutes 

at the beginning of committee 

deliberations and for approximately 30 

minutes near the end of the 

deliberations. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before November 9, 2004, 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.

Closed Committee Deliberations: On 

November 30, 2004, from 8 a.m. to 8:30 

a.m., the meeting will be closed to 

permit FDA to present to the committee 

trade secret and/or confidential 

commercial information (5 U.S.C. 

552b(c)(4)) relating to pending issues 

and applications.

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 AnnMarie 

Williams, Conference Management 

Staff, at 301–594–1283, ext. 113 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: October 22, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–24191 Filed 10–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0453]

Draft Revised Compliance Policy 

Guide ‘‘Sec. 560.400—Imported Milk 

and Cream—Federal Import Milk Act 

(CPG 7119.05);’’ Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft revision of the 

compliance policy guide (CPG) entitled 

‘‘Sec. 560.400—Imported Milk and 

Cream—Federal Import Milk Act.’’ The 

draft CPG provides guidance on the 

Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Notices 63159

applicability of the Federal Import Milk 

Act (FIMA) to imported milk and cream.

DATES: Submit written or electronic 

comments on the draft revised CPG by 

November 29, 2004. General comments 

on agency guidance documents are 

welcome any time.

ADDRESSES: Submit written requests for 

single copies of the draft revision of the 

CPG entitled ‘‘Sec. 560.400—Imported 

Milk and Cream—Federal Import Milk 

Act’’ to the Division of Compliance 

Policy (HFC–230), Office of 

Enforcement, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that 

office in processing your request, or fax 

your request to 240–632–6861. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the document.

Submit written comments 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.

FOR FURTHER INFORMATION CONTACT:

Esther Lazar, Center for Food Safety and 

Applied Nutrition (HFS–306), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740–3835, 

301–436–1485, FAX: 301–436–2632.

SUPPLEMENTARY INFORMATION:

I. Background

The FIMA (21 U.S.C. 141 et seq.) 

prohibits the importation into the 

United States of milk and cream without 

a valid permit from the Secretary of 

Health and Human Services. FDA is 

revising the CPG to clarify and update 

its policy regarding which dairy 

products require permits under the 

FIMA. As explained in the draft CPG, 

FDA intends to consider the following 

dairy products to be subject to the 

FIMA’s permit requirement for 

importation into the United States:

• Milk, lowfat milk, skim milk, 

fortified milk, flavored milk, 

concentrated milk, evaporated milk, 

sweetened condensed milk, ultra 

filtered milk.

• Cream, half-and-half, heavy cream, 

light cream, and light whipping cream.

FDA does not intend to require a 

FIMA permit for the following dairy 

products:

• Sour cream, cultured milk, acidified 

milk, yogurt, cheese, ice cream, and 

eggnog.

• Dried milk, nonfat dry milk, nonfat 

dry milk fortified with vitamins A and 

D, and other dehydrated milk products.

• Any dairy product for which a 

permit is otherwise required, if it has 

been processed and packaged in 

hermetically sealed containers so as to 

be commercially sterile in accordance 

with the requirements of 21 CFR 108.35 

and 21 CFR part 113.

FDA 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). 

The draft guidance is being issued as a 

level 1 draft guidance consistent with 

GGPs. The draft revised CPG represents 

the agency’s current thinking on the 

applicability of the FIMA to imported 

milk and cream. 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 statues 

and regulations.

II. 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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4.p.m., Monday through Friday.

III. Electronic Access

A copy of the draft revised CPG may 

be downloaded to a personal computer 

with access to the Internet. The Office 

of Regulatory Affairs home page 

includes the draft revised CPG and may 

be accessed at http://www.fda.gov/ora

under ‘‘Compliance Reference.’’

Dated: October 22, 2004.

John Marzilli,

Acting Associate Commissioner for 

Regulatory Affairs.

[FR Doc. 04–24153 Filed 10–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Data Collection; Comment 

Request Survey of Colorectal Cancer 

Screening Policies, Programs, and 

Systems in U.S. Health Plans

SUMMARY: In compliance with the 

provisions of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comments on 

proposed data collection projects, the 

National Institutes of Health (NIH), 

National Cancer Institute (NCI) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget for review and 

approval. 

Proposed Collection: Title: Survey of 

Colorectal Cancer Screening Policies, 

Programs, and Systems in U.S. Health 

Plans. Type of Information Collection 

Request: New. Need and Use of 

Information Collection: This study will 

obtain information on policies, 

programs, and practices for colorectal 

cancer screening among health plans in 

the U.S. The purpose of the study is to 

assess (1) Health plan policies, 

programs, and practices for colorectal 

cancer screening; (2) health plan 

activities in response to the National 

Committee on Quality Assurance’s new 

Health Employer Data Information Set 

measure for colorectal cancer screening; 

and (3) characteristics of health plans 

and plan policies and activities that may 

be associated with higher rates of 

colorectal cancer screening. A 

questionnaire will be administered by 

mail or Internet using a national sample 

of health plans. Study participants will 

be health plan medical directors or 

administrators, and they will select their 

preferred response mode. Burden 

estimates are as follows:

Estimated number respondents 

Estimated number responses 

per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

hours 

520 ......................................................................................................................................... 1 0.333 173 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(a) Whether the proposed collection of 

information is necessary for the 

performance of the functions of the 

agency, including whether the 

information shall have practical utility;