Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability; Extension of Comment Period, 68820-68821 [E6-20030]

Download as PDF 68820 Federal Register / Vol. 71, No. 228 / Tuesday, November 28, 2006 / Notices ycherry on PROD1PC61 with NOTICES of premixed LVPs and SVPs containing different medications (among different product lines from the same manufacturer and across different manufacturer product lines)? 2. Would the use of color differentiation on labels prevent medication errors? Can different colors be used on intravenous bags? If not, what are the barriers and possible ways to address them? 3. What information currently required to appear on intravenous container labels can be eliminated or placed elsewhere in order to make room for more important information such as barcodes, larger font size for drug names, new standard ways to express drug concentration, and product warnings? How can industry make the best use of the limited space on labels? What type of standards for layout and type size would need to be applied to correct for the confusion among the products? 4. How does the lack of standardization in the expression of medication concentrations on labels contribute to error? How can we standardize the expression of drug concentrations on IV drug container labels? 5. How do the similar labels for Sterile Water for Injection, Sterile Water for Irrigation, and Sterile Water for Inhalation lead to medication errors (i.e., deaths in some instances have been reported)? How can the label for sterile water be improved to minimize the risk of confusing the different routes of administration? 6. What strategies are there to prevent inadvertent administration of solutions not intended for parenteral IV use? 7. What are the regulatory, technological, and resource (cost) barriers that would need to be eliminated to correct the challenges identified today, if any? What are the practical resolutions to address these challenges? III. Registration, Requests to Speak, Agenda, and Presentations No registration is required to attend the meeting. Seating will be on a firstcome, first-served basis. If you need special accommodations due to a disability, please inform the contact person (see FOR FURTHER INFORMATION CONTACT). Interested persons may request to speak at the meeting (see FOR FURTHER INFORMATION CONTACT). Statements from the public will be scheduled between 2:45 p.m. and 3:45 p.m., and the time allotted for each speaker will be limited. Requests to speak at the meeting should include: (1) The specific topic or issue VerDate Aug<31>2005 15:42 Nov 27, 2006 Jkt 211001 to be addressed, (2) a brief summary of remarks, and (3) the participant’s name, address, telephone number, and e-mail. The agenda for the public meeting will be available on FDA’s Center for Drug Evaluation and Research (CDER) Web site at: https://www.fda.gov/cder/ meeting/parenteralllabeling.htm. After the meeting, the agenda, presentations, and transcript will be placed on file in the Division of Dockets Management under the docket number found in the heading of this document and on CDER’s Web site identified in the previous sentence. IV. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the topics discussed in this document (see DATES). Submit 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Transcripts Copies of the transcript may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857, approximately 20 working days after the meeting at a cost of 10 cents per page or on compact disc at a cost of $14.25 each. You may also examine the transcript at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–20035 Filed 11–27–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is extending the comment period on the draft guidance entitled ‘‘Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.’’ FDA announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52799). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, FDA has decided to extend the comment period. DATES: Submit written or electronic comments on this draft guidance by March 5, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 240–276–3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this 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. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276– 0490, ext. 162. SUPPLEMENTARY INFORMATION: [Docket No. 2006D–0336] I. Background Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability; Extension of Comment Period FDA is extending the comment period on the draft guidance ‘‘Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.’’ This draft guidance is intended to help eliminate confusion regarding particular marketing practices among ASR manufacturers. With the draft guidance document, FDA seeks to advise ASR AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1 Federal Register / Vol. 71, No. 228 / Tuesday, November 28, 2006 / Notices manufacturers that it views certain practices as being inconsistent with the marketing of an ASR, as defined in Sec. 864.4020. As the draft guidance document explains, when an ASR is marketed in certain ways, FDA views the product as no longer being an ASR within the meaning of Sec. 860.4020. FDA issued this draft guidance on September 7, 2006. The initial comment period on the draft guidance closes on December 6, 2006, but at the request of in vitro diagnostic device stakeholders, FDA has decided to extend the comment period for an additional 90 days, until March 5, 2007. II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive ‘‘Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document, or send a fax request to 240–276–3151 to receive a hard copy. Please use the document number 1590 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. ycherry on PROD1PC61 with NOTICES III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. 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. Received comments may be seen in the Division VerDate Aug<31>2005 15:42 Nov 27, 2006 Jkt 211001 of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–20030 Filed 11–27–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0310] Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events,’’ dated November 2006. The guidance document provides sponsors of gene therapy studies with recommendations regarding collection of data on delayed adverse events in subjects who have been exposed to investigational gene therapy products. The guidance announced in this notice finalizes the draft guidance entitled ‘‘Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events,’’ dated August 2005, and supplements the recommendations for study subject long-term follow-up in the ‘‘Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors’’ (Retroviral Vector guidance), dated November 2006. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the 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 guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 68821 for electronic access to the guidance document. Submit written comments on the 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 document entitled ‘‘Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events,’’ dated November 2006. This guidance provides to sponsors of gene therapy studies recommendations on the following: (1) Methods to assess the risk of gene-therapy-related delayed adverse events following exposure to investigational gene therapy products, (2) guidance for determining the likelihood that long-term follow-up observations on study subjects will provide scientifically meaningful information, and (3) specific advice regarding the duration and design of long-term follow-up observations. In the Federal Register of August 23, 2005 (70 FR 49296), FDA announced the availability of the draft guidance entitled ‘‘Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events,’’ dated August 2005. FDA received numerous comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes includes the following: (1) Clarification on topics not included in the guidance; (2) revised recommendations for preclinical study design to assess vector biodistribution and persistence; and (3) revised recommendations for data collection and data reporting in trials involving integrated vectors (e.g., retroviral vectors). The guidance announced in this notice finalizes the draft guidance entitled ‘‘Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events,’’ dated August 2005. This guidance also supplements the recommendations in the Retroviral Vector guidance, dated November 2006, for study subject long-term follow-up. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Notices]
[Pages 68820-68821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0336]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Commercially Distributed Analyte Specific Reagents (ASRs): 
Frequently Asked Questions; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period on the draft guidance entitled ``Commercially 
Distributed Analyte Specific Reagents (ASRs): Frequently Asked 
Questions.'' FDA announced the availability of this draft guidance in 
the Federal Register of September 7, 2006 (71 FR 52799). The initial 
comment period closes on December 6, 2006. To provide interested 
persons additional time to review and submit comments on the draft 
guidance, FDA has decided to extend the comment period.

DATES: Submit written or electronic comments on this draft guidance by 
March 5, 2007. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Commercially Distributed Analyte Specific 
Reagents (ASRs): Frequently Asked Questions'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this 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. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0490, ext. 162.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is extending the comment period on the draft guidance 
``Commercially Distributed Analyte Specific Reagents (ASRs): Frequently 
Asked Questions.'' This draft guidance is intended to help eliminate 
confusion regarding particular marketing practices among ASR 
manufacturers. With the draft guidance document, FDA seeks to advise 
ASR

[[Page 68821]]

manufacturers that it views certain practices as being inconsistent 
with the marketing of an ASR, as defined in Sec. 864.4020. As the draft 
guidance document explains, when an ASR is marketed in certain ways, 
FDA views the product as no longer being an ASR within the meaning of 
Sec. 860.4020.
    FDA issued this draft guidance on September 7, 2006. The initial 
comment period on the draft guidance closes on December 6, 2006, but at 
the request of in vitro diagnostic device stakeholders, FDA has decided 
to extend the comment period for an additional 90 days, until March 5, 
2007.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Commercially Distributed Analyte 
Specific Reagents (ASRs): Frequently Asked Questions,'' you may either 
send an email request to dsmica@fda.hhs.gov to receive an electronic 
copy of the document, or send a fax request to 240-276-3151 to receive 
a hard copy. Please use the document number 1590 to identify the 
guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http:/
/www.fda.gov/ohrms/dockets.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. 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. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20030 Filed 11-27-06; 8:45 am]
BILLING CODE 4160-01-S

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