Draft Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods; Availability, 57609-57610 [05-19727]

Download as PDF Federal Register / Vol. 70, No. 190 / Monday, October 3, 2005 / Notices 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 VerDate Aug<31>2005 17:26 Sep 30, 2005 Jkt 205001 transcribed as stipulated in § 15.30(b). The transcript will be available on the Internet at https://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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 57609 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 https:// 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 E:\FR\FM\03OCN1.SGM 03OCN1 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 VerDate Aug<31>2005 17:26 Sep 30, 2005 Jkt 205001 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 https://www.fda.gov/cber/guidelines.htm or https://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. Submit written or electronic comments on the draft guidance by DATES: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 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 https:// 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 E:\FR\FM\03OCN1.SGM 03OCN1

Agencies

[Federal Register Volume 70, Number 190 (Monday, October 3, 2005)]
[Notices]
[Pages 57609-57610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19727]


-----------------------------------------------------------------------

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 https://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

[[Page 57610]]

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; Sec. Sec.  
211.22, 211.80, 211.100(b), and 211.160 were approved under OMB control 
number 0910-0139; Sec.  610.2 was approved under OMB control number 
0910-0206; and Sec. Sec.  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 https://www.fda.gov/cber/guidelines.htm or https://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

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