Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 57609 

be the Acting Commissioner or his 

designee. The presiding officer will be 

accompanied by a panel of FDA 

employees with relevant expertise. 

Persons who wish to participate in the 

part 15 hearing must file a written or 

electronic notice of participation with 

the Division of Dockets Management 

(see ADDRESSES and DATES). To ensure 

timely handling, any outer envelope 

should be clearly marked with the 

docket number listed in brackets in the 

heading of this notice along with the 

statement ‘‘FDA’s Communication of 

Drug Safety Information; Public 

Hearing.’’ Groups should submit two 

written copies. The notice of 

participation should contain the 

potential presenter’s name; address; 

telephone number; affiliation, if any; the 

sponsor of the presentation (e.g., the 

organization paying travel expenses or 

fees), if any; a brief summary of the 

presentation; and the approximate 

amount of time requested for the 

presentation. The agency requests that 

interested persons and groups having 

similar interests consolidate their 

comments and present them through a 

single representative. After reviewing 

the notices of participation and 

accompanying information, FDA will 

schedule each appearance and notify 

each participant of the time allotted to 

the presenter and the approximate time 

that presenter’s oral testimony is 

scheduled to begin. If time permits, FDA 

may allow interested persons attending 

the hearing who did not submit a 

written or electronic notice of 

participation in advance to make an oral 

presentation at the conclusion of the 

hearing. The hearing schedule will be 

available at the hearing. After the 

hearing, the schedule will be placed on 

file in the Division of Dockets 

Management (see ADDRESSES) under the 

docket number listed in brackets in the 

heading of this notice. 

Under § 15.30(f), the hearing is 

informal, and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. 

Public hearings under part 15 are 

subject to FDA’s policy and procedures 

for electronic media coverage of FDA’s 

public administrative proceedings (21 

CFR part 10, subpart C). Under § 10.205 

(21 CFR 10.205), representatives of the 

electronic media may be permitted, 

subject to certain limitations, to 

videotape, film, or otherwise record 

FDA’s public administrative 

proceedings, including presentations by 

participants. The hearing will be 

transcribed as stipulated in § 15.30(b). 

The transcript will be available on the 

Internet at http://www.fda.gov/ohrms/ 

dockets/default.htm, and orders for 

copies of the transcript can be placed at 

the meeting or through the Division of 

Dockets Management (see ADDRESSES). 

Any handicapped persons requiring 

special accommodations to attend the 

hearing should direct those needs to the 

contact person (see FOR FURTHER

INFORMATION CONTACT). 

To the extent that the conditions for 

the hearing, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

these provisions as specified in 

§ 15.30(h). 

IV. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic notices 

of participation and comments for 

consideration at the hearing (see DATES). 

Submit a single copy of written or 

electronic notices of participation and 

comments, or two paper copies of any 

mailed notices of participation and 

comments, 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. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday. 

Dated: September 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19759 Filed 9–30–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0330] 

Draft Guidance for Industry and FDA 

Review Staff on Collection of Platelets 

by Automated Methods; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry and FDA 

Review Staff: Collection of Platelets by 

Automated Methods’’ dated September 

2005. The draft guidance provides blood 

establishments and FDA staff revised 

recommendations for the collection of 

Platelets by automated methods 

(plateletpheresis). The draft guidance is 

intended to help blood establishments 

ensure donor safety and the safety, 

purity, and potency of Platelets 

collected by an automated blood cell 

separator device. For the purpose of this 

document, Platelets collected by 

automated methods will be referred to 

by the product name ‘‘Platelets, 

Pheresis.’’ The draft guidance contains 

recommendations for appropriate 

criteria for a biologics license 

application or supplement for 

manufacturing Platelets, Pheresis. When 

finalized, this draft guidance will 

replace the October 1988 ‘‘Revised 

Guideline for the Collection of Platelets, 

Pheresis.’’

DATES: Submit written or electronic 

comments on the draft guidance by 

January 3, 2006, to ensure their 

adequate consideration in preparation of 

the final guidance. General comments 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1–

800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit written comments on the draft 

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. 

FOR FURTHER INFORMATION CONTACT: 

Brenda R. Friend, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry and FDA Review Staff: 

Collection of Platelets by Automated 

Methods’’ dated September 2005. The 

draft guidance provides blood 

establishments and FDA staff revised 

recommendations for the collection of 

Platelets by automated methods 

(plateletpheresis). FDA has received 

new information since the issuance of 

the October 1998 ‘‘Revised Guideline for 

57610 Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 

the Collection of Platelets, Pheresis.’’ In 

addition, in recent years, many 

improvements have been made in 

automated blood cell separator 

technology and blood cell counting 

methods. Automated blood cell 

separator devices are now capable of 

various plateletpheresis collection 

procedures including, but not limited 

to, collection of double and triple 

platelet components obtained during a 

single procedure; use of in-process 

leukocyte reduction; collection of 

concurrent plasma components; and 

collection of concurrent Red Blood Cell 

components. When finalized, the draft 

guidance will replace the October 1988 

guideline. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. 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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collections of information in 

this guidance are under FDA’s 

regulations at parts 211, 601, 606, 610, 

and 640 (21 CFR parts 211, 601, 606, 

610, and 640). Part 211, subpart J 

(Records and Reports) was approved 

under OMB control number 0910–0139; 

part 606, subpart I (Records and 

Reports) was approved under OMB 

control numbers 0910–0116 and 0910–

0458. Sections 606.100(b) and (c), 

606.110(a), 606.121, 606.122, 640.25, 

and 640.27 were approved under OMB 

control number 0910–0116; §§ 211.22, 

211.80, 211.100(b), and 211.160 were 

approved under OMB control number 

0910–0139; § 610.2 was approved under 

OMB control number 0910–0206; and 

§§ 601.12 and 610.60 were approved 

under OMB Control No. 0910–0338. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding 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 the 

brackets in the heading of this 

document. A copy of the draft 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

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

default.htm. 

Dated: September 12, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19727 Filed 9–30–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0390] 

International Conference on 

Harmonisation; Draft Guidance on 

E2B(R) Clinical Safety Data 

Management: Data Elements for 

Transmission of Individual Case Safety 

Reports; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘E2B(R) Clinical Safety Data 

Management: Data Elements for 

Transmission of Individual Case Safety 

Reports.’’ The draft guidance was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance, which revises 

previous guidance on the same topic, 

provides standardized data elements for 

the transmission of individual case 

safety reports for preapproval and 

postapproval reporting periods. The 

revisions in this draft guidance include 

additional information and 

clarifications for the electronic 

transmission of individual case safety 

reports. The draft guidance is intended 

to be used with other ICH 

recommendations for electronic 

transmissions. 

DATES: Submit written or electronic 

comments on the draft guidance by 

October 28, 2005. General comments on 

agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written comments 

on the draft 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. 

Submit written requests for single 

copies of the draft 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; or the Office of 

Communication, Training and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. The draft 

guidance may also be obtained by mail 

by calling the Center for Biologics 

Evaluation and Research (CBER) Voice 

Information System at 1–800–835–4709 

or 301–827–1800. Send two selfaddressed adhesive labels to assist the 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Roger 

Goetsch, Center for Drug Evaluation 

and Research (HFD–410), Food and 

Drug Administration, 12300 

Twinbrook Pkwy., Rockville, MD 

20851, 301–770–9299, or Lise 

Stevens-Hawkins, Center for 

Biologics Evaluation and Research 

(HFM–220), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–6085. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical