59350 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices 

Dated: June 3, 2005. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC). 

[FR Doc. 05–20369 Filed 10–11–05; 8:45 am] 

BILLING CODE 4160–70–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee on Immunization 

Practices 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following Federal 

Committee meeting. 

Name: Advisory Committee on 

Immunization Practices (ACIP). 

Times and Dates: 

8:30 a.m.–5:15 p.m., October 26, 2005. 

8 a.m.–3:30 p.m., October 27, 2005. 

Place: Atlanta Marriott Century Center, 

2000 Century Boulevard, N.E., Atlanta, 

Georgia 30345–3377. 

Status: Open to the public, limited only by 

the space available. 

Purpose: The Committee is charged with 

advising the Director, CDC, on the 

appropriate uses of immunizing agents. In 

addition, under 42 United States Code 1396s, 

the Committee is mandated to establish and 

periodically review and, as appropriate, 

revise the list of vaccines for administration 

to vaccine-eligible children through the 

Vaccines for Children (VFC) program, along 

with schedules regarding the appropriate 

periodicity, dosage, and contraindications 

applicable to the vaccines. 

Matters to Be Discussed: The agenda will 

include discussions on influenza; 

recommendations for use of Hepatitis A 

vaccine among children; VFC vote on 

Hepatitis A; adult Hepatitis B vaccine 

recommendation; varicella zoster immune 

globulin; recommended childhood and 

adolescent immunization schedules; use of 

Tdap vaccine; prevention of rotavirus 

gastroenteritis; Measles, Mumps, Rubella 

Vaccine (MMRV) recommendation; VFC vote 

on MMRV; Human Papailloma Virus vaccine; 

general recommendations on immunization; 

herpes zoster; and Departmental updates. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Demetria Gardner, Epidemiology and 

Surveillance Division, National 

Immunization Program, CDC, 1600 Clifton 

Road, NE., (E–61), Atlanta, Georgia 30333, 

telephone 404/639–8096, fax 404/639–8616. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both the CDC and ATSDR. 

Dated: October 5, 2005. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 05–20381 Filed 10–11–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0393] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Investigational 

New Drug Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements under which the clinical 

investigation of the safety and 

effectiveness of unapproved new drugs 

and biological products can be 

conducted. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 12, 2005. 

ADDRESSES: Submit electronic 

comments on the collection of 

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

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Investigational New Drug Regulations—

21 CFR Part 312 (OMB Control Number 

0910–0014)—Extension 

FDA is requesting OMB approval for 

the reporting and recordkeeping 

requirements contained in the FDA 

regulation ‘‘Investigational New Drug 

Application’’ in part 312 (21 CFR part 

312). This regulation implements 

provisions of section 505(i) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 355(i)) to issue 

regulations under which the clinical 

investigation of the safety and 

effectiveness of unapproved new drugs 

and biological products can be 

conducted. 

FDA is charged with implementing 

statutory requirements that drug 

products marketed in the United States 

be shown to be safe and effective, 

properly manufactured, and properly 

labeled for their intended uses. Section 

505(a) of the act provides that a new 

drug may not be introduced or delivered 

for introduction into interstate 

commerce in the United States unless 

FDA has previously approved a new 

drug application (NDA). FDA approves 

Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices 59351 

an NDA only if the sponsor of the 

application first demonstrates that the 

drug is safe and effective for the 

conditions prescribed, recommended, or 

suggested in the product’s labeling. 

Proof must consist, in part, of adequate 

and well-controlled studies, including 

studies in humans, that are conducted 

by qualified experts. The IND 

regulations establish reporting 

requirements that include an initial 

application as well as amendments to 

that application, reports on significant 

revisions of clinical investigation plans, 

and information on a drug’s safety or 

effectiveness. In addition, the sponsor is 

required to give FDA an annual 

summary of the previous year’s clinical 

experience. Submissions are reviewed 

by medical officers and other agency 

scientific reviewers assigned 

responsibility for overseeing the specific 

study. The IND regulations also contain 

recordkeeping requirements that pertain 

to the responsibilities of sponsors and 

investigators. The detail and complexity 

of these requirements are dictated by the 

scientific procedures and human subject 

safeguards that must be followed in the 

clinical tests of investigational new 

drugs. 

The IND information collection 

requirements provide the means by 

which FDA can do the following: (1) 

Monitor the safety of ongoing clinical 

investigations; (2) determine whether 

the clinical testing of a drug should be 

authorized; (3) ensure production of 

reliable data on the metabolism and 

pharmacological action of the drug in 

humans; (4) obtain timely information 

on adverse reactions to the drug; (5) 

obtain information on side effects 

associated with increasing doses; (6) 

obtain information on the drug’s 

effectiveness; (7) ensure the design of 

well-controlled, scientifically valid 

studies; (8) obtain other information 

pertinent to determining whether 

clinical testing should be continued and 

information related to the protection of 

human subjects. Without the 

information provided by industry in 

response to the IND regulations, FDA 

cannot authorize or monitor the clinical 

investigations which must be conducted 

prior to authorizing the sale and general 

use of new drugs. These reports enable 

FDA to monitor a study’s progress, to 

assure subject safety, to assure that a 

study will be conducted ethically, and 

to increase the likelihood that the 

sponsor will conduct studies that will 

be useful in determining whether the 

drug should be marketed and available 

for use in medical practice. 

There are two forms that are required 

under part 312. The first is Form FDA–

1571 ‘‘Investigational New Drug 

Application.’’ A person who intends to 

conduct a clinical investigation submits 

this form to FDA. It includes the 

following information: (1) A cover sheet 

containing background information on 

the sponsor and investigator, (2) a table 

of contents, (3) an introductory 

statement and general investigational 

plan, (4) an investigator’s brochure 

describing the drug substance, (5) a 

protocol for each planned study, (6) 

chemistry, manufacturing, and control 

information for each investigation, (7) 

pharmacology and toxicology 

information for each investigation, and 

(8) previous human experience with the 

investigational drug. 

The second form required under part 

312 is Form FDA–1572 ‘‘Investigator 

Statement.’’ Before permitting an 

investigator to begin participation in an 

investigation, the sponsor must obtain 

and record this form. It includes 

background information on the 

investigator and the investigation, and a 

general outline of the planned 

investigation and the study protocol. 

FDA is requesting OMB approval for 

the following reporting and 

recordkeeping requirements in part 312: 

TABLE 1. 

REPORTING REQUIREMENTS 

21 CFR Section Requirements 

312.7(d) .................................. Applications for permission to sell an investigational new drug. 

312.10(a) ................................ Applications for waiver of requirements under part 312. Estimates for this requirement are included under 

§§ 312.23 and 312.31. 

312.20(c) ................................ Applications for investigations involving an exception from informed consent under § 50.24 (21 CFR 50.24). Estimates for this requirement are included under § 312.23. 

312.23 .................................... INDs (content and format). 

(a)(1) ................................... Cover sheet FDA–1571. 

(a)(2) ................................... Table of contents. 

(a)(3) ................................... Investigational plan for each planned study. 

(a)(5) ................................... Investigator’s brochure. 

(a)(6) ................................... Protocols—phases 1, 2, and 3. 

(a)(7) ................................... Chemistry, manufacturing, and control information. 

(a)(7)(iv)(a), (a)(7)(iv)(b), 

and (a)(7)(iv)(c) 

A description of the drug substance, a list of all components, and any placebo used. 

(a)(7)(iv)(d) ......................... Labeling: Copies of labels and labeling to be provided each investigator. 

(a)(7)(iv)(e) ......................... Environmental impact analysis regarding drug manufacturing and use. 

(a)(8) ................................... Pharmacological and toxicology information. 

(a)(9) ................................... Previous human experience with the investigational drug. 

(a)(10) ................................. Additional information. 

(a)(11) ................................. Relevant information. 

(f) ........................................ Identification of exception from informed consent. 

312.30 .................................... Protocol amendments. 

(a) ....................................... New protocol. 

(b) ....................................... Change in protocol. 

(c) ....................................... New investigator. 

(d) ....................................... Content and format. 

(e) ....................................... Frequency. 

312.31 .................................... Information amendments. 

59352 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices 

TABLE 1.—Continued 

REPORTING REQUIREMENTS 

21 CFR Section Requirements 

(b) ....................................... Content and format. 

Chemistry, toxicology, or technical information. 

312.32 .................................... Safety reports. 

(c)(1) ................................... Written reports to FDA and to investigators. 

(c)(2) ................................... Telephone reports to FDA for fatal or life-threatening experience. 

(c)(3) ................................... Format or frequency. 

(d) ....................................... Followup submissions. 

312.33 .................................... Annual reports. 

(a) ....................................... Individual study information. 

(b) ....................................... Summary information. 

(b)(1) ................................... Adverse experiences. 

(b)(2) ................................... Safety report summary. 

(b)(3) ................................... List of fatalities and causes of death. 

(b)(4) ................................... List of discontinuing subjects. 

(b)(5) ................................... Drug action. 

(b)(6) ................................... Preclinical studies and findings. 

(b)(7) ................................... Significant changes. 

(c) ....................................... Next year general investigational plan. 

(d) ....................................... Brochure revision. 

(e) ....................................... Phase I protocol modifications. 

(f) ........................................ Foreign marketing developments. 

312.35 .................................... Treatment use of investigational new drugs. 

(a) ....................................... Treatment protocol submitted by an investigational new drug sponsor. 

(b) ....................................... Treatment investigational new drug application (IND) submitted by licensed practitioner. 

312.36 .................................... Requests for emergency use of an investigational new drug. 

312.38(b) and (c) ................... Notification of withdrawal of an investigational new drug. 

312.42(e) ................................ Sponsor requests that a clinical hold be removed and submits a complete response to the issues identified in 

the clinical hold order. 

312.44(c) and (d) ................... Opportunity for sponsor response to FDA when an investigational new drug is terminated. 

312.45(a) and (b) ................... Sponsor request for, or response to, inactive status determination of an investigational new drug. 

312.47(b) ................................ ‘‘End-of-Phase 2’’ meetings and ‘‘Pre-NDA’’ meetings. 

312.53(c) ................................ Investigator information. Investigator report (Form FDA–1572) and narrative; Investigator’s background information; phase 1 outline of planned investigation; and phase 2 outline of study protocol; financial disclosure information. 

312.54(a) and (b) ................... Sponsor submissions concerning investigations involving an exception from informed consent under § 50.24. 

312.55(b) ................................ Sponsor reports to investigators on new observations, especially adverse reactions and safe use. Only ‘‘new observations’’ are estimated under this section; investigator brochures are included under § 312.23. 

312.56(b), (c), and (d) ........... Sponsor monitoring of all clinical investigations, investigators, and drug safety; notification to FDA. 

312.58(a) ................................ Sponsor’s submission of records to FDA on request. 

312.64 .................................... Investigator reports to the sponsor. 

(a) ....................................... Progress reports. 

(b) ....................................... Safety reports 

(c) ....................................... Final reports. 

(d) ....................................... Financial disclosure reports. 

312.66 .................................... Investigator reports to Institutional Review Board. Estimates for this requirement are included under § 312.53. 

312.70(a) ................................ Investigator disqualification; opportunity to respond to FDA. 

312.83 .................................... Sponsor submission of treatment protocol. Estimates for this requirement are included under §§ 312.34 and 

312.35. 

312.85 .................................... Sponsors conducting phase 4 studies. Estimates for this requirement are included under § 312.23 in OMB control number 0910–0014, and §§ 314.50, 314.70, and 314.81 (21 CFR 314.50, 314.70, and 314.81) in OMB 

control number 0910–0001. 

312.110(b) .............................. Request to export an investigational drug. 

312.120(b) and (c)(2) ............. Sponsor’s submission to FDA for use of foreign clinical study to support an IND. Estimates for this requirement 

are included under §§ 312.23 and 312.30 in OMB control number 0910–0014, and §§ 314.50, 314.60, and 

314.70 (21 CFR 314.60) in OMB control number 0910–0001. 

312.120(c)(3) ......................... Sponsor’s report to FDA on findings of independent review committee on foreign clinical study. Estimates for this 

requirement are included under §§ 312.23 and 312.30 in OMB control number 0910–0014, and §§ 314.50, 

314.60, and 314.70 in OMB control number 0910–0001. 

Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices 59353 

TABLE 1.—Continued 

REPORTING REQUIREMENTS 

21 CFR Section Requirements 

312.130(d) .............................. Request for disclosable information for investigations involving an exception from informed consent under 

§ 50.24. 

RECORDKEEPING REQUIREMENTS 

21 CFR Section Requirements 

312.52(a) ................................ Transfer of obligations to a contract research organization. 

312.57(a) and (b) ................... Sponsor recordkeeping. 

312.59 .................................... Sponsor recordkeeping of disposition of unused supply of drugs. Estimates for this requirement are included 

under § 312.57. 

312.62(a) ................................ Investigator recordkeeping of disposition of drugs. 

312.62(b) ................................ Investigator recordkeeping of case histories of individuals. 

312.160(a)(3) ......................... Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests. 

312.160(c) .............................. Shipper records of alternative disposition of unused drugs. 

In tables 2 and 3 of this document, the 

estimates for ‘‘No. of Respondents,’’

‘‘No. of Responses per Respondent,’’

and ‘‘Total Annual Responses’’ were 

obtained from the Center for Drug 

Evaluation and Research (CDER) and the 

Center for Biologics Evaluation and 

Research (CBER) reports and data 

management systems for submissions 

received in 2004 and from other sources 

familiar with the number of submissions 

received under part 312. The estimates 

for ‘‘Hours per Response’’ were made by 

CDER and CBER individuals familiar 

with the burden associated with these 

reports and from estimates received 

from the pharmaceutical industry. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR HUMAN DRUGS1

REPORTING BURDEN 

21 CFR Section No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

312.7(d) 9 1 .4 13 24 7,488 

312.23(a) through (f) 1,245 1 .3 1,597 1,600 2,555,200 

312.30(a) through (e) 1,257 13 .3 16,687 284 4,739,108 

312.31(b) 1,116 7 .4 8,298 100 829,800 

312.32(c) and (d) 649 24 .7 16,052 32 513,664 

312.33(a) through (f) 1,821 2 .5 4,516 360 1,625,760 

312.35(a) and (b) 5 1 .2 6 300 1,800 

312.36 109 1 .1 121 16 1,936 

312.38(b) and (c) 536 1 .3 677 28 18,965 

312.42(e) 97 1 .2 118 284 33,512 

312.44(c) and (d) 44 1 45 16 720 

312.45(a) and (b) 185 1 .5 271 12 3,252 

312.47(b) 215 1 .7 355 160 56,800 

312.53(c) 21,194 1 21,194 80 1,695,520 

312.54(a) and (b) 0 0 0 48 0 

312.55(b) 807,400 1 807,400 48 38,755,200 

312.56(b), (c), and (d) 13 1 13 80 1,040 

59354 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices 

TABLE 2.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR HUMAN DRUGS1—Continued 

REPORTING BURDEN 

21 CFR Section No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

312.58(a) 88 3 .8 340 8 2,720 

312.64(a) through (d) 31,791 1 31,791 24 762,984 

312.70(a) 4 1 4 40 160 

312.110(b) 33 8 .3 276 75 20,700 

312.130(d) 5 1 5 8 40 

Total reporting burden 51,626,369 

RECORDKEEPING BURDEN 

21 CFR Section No. of 

Recordkeepers 

No. of Records 

per Recordkeeper 

Total Annual 

Records 

Hours per 

Record Total Hours 

312.52(a) 335 1 .5 488 2 976 

312.57(a) and (b) 335 119 .8 40,148 100 4,014,800 

312.62(a) 20,074 1 20,074 40 802,960 

312.62(b) 200,740 1 200,740 40 8,029,600 

312.160(a)(3) 372 1 .5 542 .5 271 

312.160(c) 372 1 .5 542 .5 271 

Total recordkeeping burden 12,848,878 

Human drugs total burden hours 64,475,247 

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

TABLE 3.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR BIOLOGICS1

REPORTING BURDEN 

21 CFR Section No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

312.7(d) 41 1 .4 58 24 1,392 

312.23(a) through (f) and 312.120(b), (c)(2), and (c)(3) 433 1 .3 557 1,808 1,007,056 

312.30(a) through (e) 590 6 .8 4,014 284 1,139,976 

312.31(b) 263 29 .3 7,700 100 770,000 

312.32(c) and (d) and 312.56(c) 294 13 .7 4,042 32 129,344 

312.33(a) through (f) and 312.56(c) 647 2 .3 1,473 360 530,280 

312.35(a) and (b) 1 1 1 300 300 

312.36 6 1 6 16 96 

312.38(b) and (c) 117 1 .3 153 28 4,284 

312.42(e) 74 1 .5 108 284 30,672 

312.44(c) and (d) 17 1 .1 18 16 288 

312.45(a) and (b) 60 1 .8 107 12 1,284 

312.47(b) 43 1 .5 66 160 10,560 

312.53(c) 348 6 .6 2,303 80 184,240 

Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices 59355 

TABLE 3.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR BIOLOGICS1—Continued 

REPORTING BURDEN 

21 CFR Section No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

312.54(a) and (b) 1 1 1 48 48 

312.55(b) 138 2 .5 347 48 16,656 

312.56(b) and (d) 14 1 .6 23 80 1,840 

312.58(a) 8 1 8 8 64 

312.64(a) through (d) 6,003 3 .5 21,185 24 508,440 

312.70(a) 6 1 6 40 240 

312.110(b) 21 1 21 75 1,575 

312.130(d) 1 1 1 8 8 

Total reporting burden 4,338,643 

RECORDKEEPING BURDEN 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

312.52(a) 139 1 .4 200 2 400 

312.57(a) and (b) 433 2 .6 1,114 100 111,400 

312.62(a) 5,570 1 5,570 40 222,800 

312.62(b) 5,570 10 55,700 40 2,228,000 

312.160(a)(3) 146 1 .4 211 0 .5 105.5 

312.160(c) 146 1 .4 211 0 .5 105.5 

Total recordkeeping burden 2,562,811 

Total biologics burden hours 6,901,454 

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

TABLE 4.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR HUMAN DRUGS AND BIOLOGICS1

Total human drugs burden hours ........................................................................................................................................................ 64,475,247 

Total biologics burden hours ............................................................................................................................................................... 6,901,454 

Total burden hours .............................................................................................................................................................................. 71,376,701 

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

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20362 Filed 10–11–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel. ‘‘Review of an Unsolicited 

P01.’’

Date: October 26, 2005. 

Time: 10 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

Bethesda, MD 20817, (Telephone Conference 

Call). 

Contact Person: Cheryl K. Lapham, PhD, 

Scientific Review Administrator, Scientific 

Review Program, National Institute of Allergy 

and Infectious Diseases, DEA/NIH/DHHS, 

6700–B Rockledge Drive, MSC 7616, Room 

3127, Bethesda, MD 20892–7616, 301–402–

4598, clapham@niaid.nih.gov.