Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 58711 

TABLE 1.— ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Form No. 21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

FDA 1997/Sanitary 

inspections of 

plants 1210.14 8 1 8 2.0 16.0 

Totals 2,425.0 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Record 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

1210.15 8 1 8 .05 0.40 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

These estimates are based on the 

number of current permit holders and 

the number of inquiries that FDA has 

received regarding requests for 

applications in the past 3 years. No 

burden has been estimated for the 

tagging requirement in § 1210.22 

because the information on the tag is 

either supplied by FDA (permit number) 

or is disclosed to third parties as a usual 

and customary part of the shipper’s 

normal business activities (type of 

product, shipper’s name and address). 

Under 5 CFR 1320.3(c)(2), the public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public is not a 

collection of information. Under 5 CFR 

1320.3(b)(2)), the time, effort, and 

financial resources necessary to comply 

with a collection of information are 

excluded from the burden estimate if 

the reporting, recordkeeping, or 

disclosure activities needed to comply 

are usual and customary because they 

would occur in the normal course of 

activities. Low burden has been 

estimated for Forms FDA 1994 and 1995 

because they are not are not used often. 

The Secretary of Health and Human 

Services has the discretion to allow 

Form FDA 1815, a duly certified 

statement signed by an accredited 

official of a foreign government, to be 

submitted in lieu of Forms FDA 1994 

and 1995. To date, Form FDA 1815 has 

been submitted in lieu of these forms. 

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20148 Filed 10–6–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0404] 

Pediatric Ethics Subcommittee of the 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of the Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee of the Food and Drug 

Administration (FDA). The meeting will 

be open to the public. 

Name of Committee: Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Pediatric 

Advisory Committee on FDA, and 

certain Department of Health and 

Human Services (HHS), regulatory 

issues. 

Date and Time: The meeting will be 

held on November 15, 2005, from 8:30 

a.m. to 4 p.m. 

Addresses: Electronic copies of the 

documents for public review can be 

viewed at the Pediatric Advisory 

Committee (PAC) Docket site at http:// 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm. (Click on the year 2005 

and scroll down to Pediatric Ethics 

Subcommittee meeting for 11–15–05.) 

Electronic comments should be 

submitted to http://www.fda.gov/ 

dockets/ecomments. Select Docket No. 

2005N–0404 entitled ‘‘Leuprolide IRB 

Referral’’ and follow the prompts to 

submit your statement. Written 

comments should be submitted to 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Please submit comments by 

4:30 p.m. on November 1, 2005. 

Received comments may be viewed on 

the FDA Web site at: http:// 

www.fda.gov/ohrms/dockets, or may be 

seen in the Division of Dockets 

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

Monday through Friday. 

Location: Washington DC North/ 

Gaithersburg Hilton, 620 Perry Pkwy., 

Gaithersburg, MD. 

Contact Person: Jan N. Johannessen, 

Office of the Commissioner (HF–33), 

Food and Drug Administration, 5600 

Fishers Lane (for express delivery, rm. 

14C–06), Rockville, MD 20857, 301–

827–6687, or by e-mail: 

jjohannessen@fda.gov. Please call the 

FDA Advisory Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

8732310001, for up-to-date information 

on this meeting. 

Agenda: The Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee will meet to discuss a 

referral by an Institutional Review 

Board (IRB) of a proposed clinical 

investigation involving children as 

subjects, that is regulated by FDA and 

may be supported by HHS. The 

proposed clinical investigation is 

entitled ‘‘Gonadotropin Releasing 

Hormone (GnRH) Agonist Test in 

Disorders of Puberty.’’ Because the 

proposed clinical investigation would 

be regulated by FDA, and conducted or 

supported by HHS, both FDA and the 

Office for Human Research Protections, 

HHS, will participate in the meeting. 

After presentation of an overview of 

the IRB referral process, background 

information on disorders of puberty and 

58712 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 

hormonal actions of leuprolide, an 

overview of the protocol and the 

referring IRB’s deliberations on the 

protocol, and a summary of public 

comments received concerning whether 

the protocol should proceed, the 

subcommittee will discuss the proposed 

protocol and develop a recommendation 

regarding whether the protocol should 

proceed. The subcommittee’s 

recommendation will then be presented 

to the FDA Pediatric Advisory 

Committee on November 16, 2005; the 

announcement of the November 16 and 

17, 2005, Pediatric Advisory Committee 

meeting can be found elsewhere in this 

issue of the Federal Register. 

Elsewhere in this issue of the Federal 

Register is also a notice announcing a 

public comment period concerning 

whether the proposed clinical 

investigation should proceed. 

Information regarding submitting 

comments during that period is 

contained in that notice. 

The background materials for the 

subcommittee meeting will be made 

publicly available no later than the day 

before the meeting and will be posted 

under the PAC Docket site at http:// 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm. (Click on the year 2005 

and scroll down to Pediatric Advisory 

Committee, Pediatric Ethics 

Subcommittee meetings.) 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person by November 4, 2005. Oral 

presentations from the public will be 

scheduled between approximately 11 

a.m. and 12 noon. 

Time allotted for each presentation 

may be limited. Those desiring to make 

formal oral presentations should notify 

the contact person by November 4, 

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 notify Jan 

Johannessen at least 7 days prior to the 

meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 3, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–20302 Filed 10–5–05; 11:25 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Pediatric 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). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. The committee 

also advises and makes 

recommendations to the Secretary of 

Health and Human Services under 45 

CFR 46.407 on research involving 

children as subjects that is conducted or 

supported by the Department of Health 

and Human Services (HHS), when that 

research is also regulated by FDA. 

Date and Time: The meeting will be 

held on Wednesday, November 16, 

2005, from 8 a.m. to 6 p.m., and 

Thursday, November 17, 2005, from 8 

a.m. to 5 p.m. 

Location: Washington DC North/ 

Gaithersburg Hilton, 620 Perry Pkwy., 

Gaithersburg, MD. 

Contact Person: Jan N. Johannessen, 

Office of Science and Health 

Coordination of the Office of the 

Commissioner (HF–33), Food and Drug 

Administration, 5600 Fishers Lane, (for 

express delivery, rm. 14C–06) Rockville, 

MD 20857, 301–827–6687, or by e-mail: 

jjohannessen@fda.gov or FDA Advisory 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 8732310001. Please call the 

Information Line for up to date 

information on this meeting. 

Agenda: On Wednesday, November 

16, 2005, the committee will hear and 

discuss the recommendation of the 

Pediatric Ethics Subcommittee from its 

meeting on November 15, 2005, 

regarding a referral by an Institution 

Review Board of a proposed clinical 

investigation involving children as 

subjects that is regulated by FDA and is 

conducted or supported by the 

Department of Health and Human 

Services. The committee will also 

discuss pediatric obesity and clinical 

trial designs for the evaluation of 

devices intended to treat pediatric 

obesity. 

On Thursday, November 17, 2005, the 

committee will continue its discussion 

of clinical trial designs for, and ethical 

issues related to, the evaluation of 

devices intended to treat pediatric 

obesity. 

The background material will become 

available no later than the day before 

the meeting and will be posted under 

the Pediatric Advisory Committee (PAC) 

Docket site at http://www.fda.gov/ 

ohrms/dockets/ac/acmenu.htm. (Click 

on the year 2005 and scroll down to 

Pediatric Advisory Committee 

meetings.) 

Procedure: 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 4, 2005. Oral 

presentations from the public will be 

scheduled on Wednesday, November 

16, 2005 between approximately 1:30 

p.m. and 2:30 p.m. and Thursday, 

November 17, 2005, between 

approximately 9:15 a.m. and 10:15 a.m. 

Time allotted for each presentation may 

be limited. Those desiring to make 

formal oral presentations should notify 

the contact person by November 4, 

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 notify Jan 

Johannessen 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).