Guidance for Industry and Food and Drug Administration Staff; Assayed and Unassayed Quality Control Material; Availability, 31589-31590 [E7-10996]

Download as PDF Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices during the regulatory review period by December 4, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, 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. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 2, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7–10915 Filed 6–6–07; 8:45 am] BILLING CODE 4160–01–S 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 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: Carol Benson, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276– 0396. SUPPLEMENTARY INFORMATION: I. Background DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1998D–1232] (formerly 98D– 1232) Guidance for Industry and Food and Drug Administration Staff; Assayed and Unassayed Quality Control Material; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry and FDA staff entitled ‘‘Assayed and Unassayed Quality Control Material.’’ The guidance describes FDA’s current practices concerning assayed an unassayed quality control material, including information to include in a 510(k) for assayed quality control material, as well as labeling recommendations. Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Assayed and Unassayed Quality Control Material’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health, Food and Drug rwilkins on PROD1PC63 with NOTICES DATES: VerDate Aug<31>2005 20:59 Jun 06, 2007 Jkt 211001 This guidance document provides recommendations to manufacturers regarding preparation of premarket notifications and labeling for quality control (QC) material. These materials are intended to monitor reliability of a test system and help minimize reporting of incorrect test results. They are often the best source of ongoing feedback that a laboratory has to monitor whether results reported to physicians are sufficiently reliable. QC materials may be marketed together with a specific test system, or alternatively, for more general use. Both assayed and unassayed QC materials are discussed in the guidance document. Both types of QC materials are subject to FDA’s Quality System Regulation (part 820 (21 CFR part 820)) and labeling regulation (§ 809.10 (21 CFR 809.10)). However, most types of unassayed QC materials are exempt from premarket notification. (See ‘‘Classification and Identification of QC Material’’ of the guidance document for exceptions.) Although premarket notifications are number required for unassayed QC materials, some aspects of this guidance document concerning labeling, stability, and matrix effects are still relevant for these materials. The draft version of this guidance was issued February 3, 1999. FDA received one set of comments on the draft guidance document during the comment period. The document reflects FDA’s consideration of the comments and has also been updated to provide clarification as needed. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 31589 II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on assayed and unassayed quality control material. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Assayed and Unassayed Quality Control Material; Availability,’’ 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 (2231) 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. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 21 CFR part 610 have been approved under OMB control number 0910–0206; the collections of information in 21 CFR part 807 have been approved under OMB control number 0910–0120; the collections of information in § 809.10 E:\FR\FM\07JNN1.SGM 07JNN1 31590 Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices have been approved under OMB control number 0910–0485; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. V. 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. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 31, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7–10996 Filed 6–6–07; 8:45 am] I. Background BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0212] Draft Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis; Availability AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis.’’ This draft guidance addresses issues regarding the development of therapy for prophylaxis and treatment of malaria. Specific topics include recommendations for preclinical development, clinical trial study design, the use of microbiological testing during clinical trials, and statistical considerations. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by September 5, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance to the VerDate Aug<31>2005 20:59 Jun 06, 2007 Jkt 211001 Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Leonard Sacks, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6178, Silver Spring, MD 20993–0002, 301– 796–1600. SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a draft guidance for industry entitled ‘‘Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis.’’ Malaria is a major global problem with the greatest burden of disease and mortality occurring in developing countries. Although cases of malaria are uncommon in the United States, antimalarial drugs have significant public health importance in the United States: Antimalarial prophylaxis is used extensively by U.S. travelers and by U.S. citizens residing in or deployed to endemic areas (e.g., military personnel). This guidance addresses the development of therapy for the prophylaxis and treatment of malaria. Overall aspects of a developmental program for antimalarial therapy are discussed. Specific topics include recommendations for preclinical development, clinical trial study design, the use of microbiological testing during clinical trials, and statistical considerations. 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 developing drug and nonvaccine biological products for the treatment and prophylaxis of malaria. 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. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 II. 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. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/ohrms/dockets/ default.htm or https://www.fda.gov/cder/ guidance/index.htm. Dated: May 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–11001 Filed 6–6–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Food Quality Indicator Device Food and Drug Administration, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the Food and Drug Administration, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent 7,014,816, issued March 21, 2006, entitled ‘‘Food Quality Indicator Device’’ [E–093–1997/ 0–US–03] and foreign counterparts; to Litmus, LLC, having a place of business in Little Rock, AR. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the manufacture, use, distribution and sale of the Food Quality Indicator Device as claimed in the licensed patent rights. DATES: Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before August 6, 2007 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, comments, E:\FR\FM\07JNN1.SGM 07JNN1

Agencies

[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31589-31590]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10996]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-1232] (formerly 98D-1232)


Guidance for Industry and Food and Drug Administration Staff; 
Assayed and Unassayed Quality Control Material; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance for industry and FDA staff entitled 
``Assayed and Unassayed Quality Control Material.'' The guidance 
describes FDA's current practices concerning assayed an unassayed 
quality control material, including information to include in a 510(k) 
for assayed quality control material, as well as labeling 
recommendations.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Assayed and Unassayed Quality Control Material'' 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 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: Carol Benson, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0396.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document provides recommendations to manufacturers 
regarding preparation of premarket notifications and labeling for 
quality control (QC) material. These materials are intended to monitor 
reliability of a test system and help minimize reporting of incorrect 
test results. They are often the best source of ongoing feedback that a 
laboratory has to monitor whether results reported to physicians are 
sufficiently reliable. QC materials may be marketed together with a 
specific test system, or alternatively, for more general use.
    Both assayed and unassayed QC materials are discussed in the 
guidance document. Both types of QC materials are subject to FDA's 
Quality System Regulation (part 820 (21 CFR part 820)) and labeling 
regulation (Sec.  809.10 (21 CFR 809.10)). However, most types of 
unassayed QC materials are exempt from premarket notification. (See 
``Classification and Identification of QC Material'' of the guidance 
document for exceptions.) Although premarket notifications are number 
required for unassayed QC materials, some aspects of this guidance 
document concerning labeling, stability, and matrix effects are still 
relevant for these materials.
    The draft version of this guidance was issued February 3, 1999. FDA 
received one set of comments on the draft guidance document during the 
comment period. The document reflects FDA's consideration of the 
comments and has also been updated to provide clarification as needed.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on assayed and unassayed quality control 
material. 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 statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Assayed and Unassayed Quality Control 
Material; Availability,'' you may either send an e-mail 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 (2231) 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.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 21 CFR part 610 have been approved under 
OMB control number 0910-0206; the collections of information in 21 CFR 
part 807 have been approved under OMB control number 0910-0120; the 
collections of information in Sec.  809.10

[[Page 31590]]

have been approved under OMB control number 0910-0485; and the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073.

V. 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. Comments received may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: May 31, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-10996 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S

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