Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Notices 57301 

that ‘‘A recall communication can be 

accomplished by telegrams, mailgrams, 

or first class letters* * *.’’ Given the 

use of the term ‘‘can,’’ we read the three 

examples as being illustrative rather 

than the sole means of accomplishing 

recall communications. Electronic 

notification is a viable alternative to 

more traditional methods. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on using electronic means to distribute 

certain product information. 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. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. 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. The draft guidance and 

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 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/oc/guidance/ 

electronic.html or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: September 27, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19731 Filed 9–28–05; 1:53 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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 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 be constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Sickle Cell Disease Clinical Research 

Network. 

Date: October 31–November 1, 2005. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Double Tree Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: William J. Johnson, PhD, 

Review Branch, Division of Extramural 

Affairs, NIH/NHLBI, 6701 Rockledge Drive, 

Bethesda, MD 20892–7924, 301–435–0317, 

johnsonw@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 23, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–19537 Filed 9–29–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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 discuss 

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 Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

NHLBI Patient-Oriented K Applications. 

Date: October 27–28, 2005. 

Time: 9 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Columbia Hotel, 10207 

Wincopin Circle, Columbia, MD 21044. 

Contact Person: Roy L White, PhD, 

Scientific Review Administrator, Division of 

Extramural Affairs, Review Branch, National 

Heart, Lung, and Blood Institute, NIH, 6701 

Rockledge Drive, Rm. 7202, Bethesda, MD 

20892–7924, 301/435–0310, 

whiterl@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 23, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–19538 Filed 9–29–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meetings 

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 

meetings. 

The meetings will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meetings will be closed to the 

public accordance with the provisions 

set forth in sections 552(b)(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 

Diabetes and Digestive and Kidney Diseases 

Initial Review Group, Kidney, Urologic and 

Hematologic Diseases D Subcommittee. 

Date: October 18–19, 2005. 

Open: October 18, 2005, 2 p.m. to 2:30 p.m. 

Agenda: To review procedures and discuss 

policy.