Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection Systems; Availability, 61829-61830 [05-21349]

Download as PDF Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Notices agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 18, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. 05–21350 Filed 10–25–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0392] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ‘‘Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.’’ This guidance document describes a means by which cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify CFTR gene mutation detection systems into class II (special controls). This guidance document is immediately in effect as the special control for CFTR gene mutation detection systems, but it remains subject to comment in accordance with the agency’s good guidance practices (GGPs). Submit written or electronic comments on this guidance at any time. DATES: VerDate Aug<31>2005 16:26 Oct 25, 2005 Jkt 208001 Submit written requests for single copies on a 3.5′′ diskette of the guidance document entitled ‘‘Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems’’ 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 301–443– 8818. 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: Zivana Tezak, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276– 0597. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying CFTR gene mutation detection systems into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document will serve as the special control for CFTR gene mutation detection systems. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification. Because of the timeframes established by section 513(f)(2) of the act, FDA has determined, under § 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 61829 to allow for public participation before issuing this guidance as a final guidance document. Therefore, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA’s GGPs regulation (§ 10.115). The guidance represents the agency’s current thinking on CFTR gene mutation detection systems. 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 To receive ‘‘Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems’’ by fax machine, call the CDRH Facts-OnDemand system at 800–899–0381 or 301–827–0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1564) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so by using the Internet. The Center for Devices and Radiological Health (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 contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork E:\FR\FM\26OCN1.SGM 26OCN1 61830 Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Notices Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910–0120). The labeling provisions addressed in the guidance have been approved by OMB under OMB control number 0910–0485. 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 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: October 17, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–21349 Filed 10–25–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002D–0307] (formerly 02D– 0307) Guidance for Industry on Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Potassium Chloride ModifiedRelease Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing.’’ This guidance document provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for modifiedrelease dosage forms of potassium chloride. DATES: Submit written or electronic comments on agency guidances at any time. VerDate Aug<31>2005 16:26 Oct 25, 2005 Jkt 208001 Submit written requests for single copies of this 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. Send one selfaddressed adhesive label to assist that office in processing your requests. 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Lizzie Sanchez, Center for Drug Evaluation and Research (HFD–650), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–5847. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing.’’ This guidance is intended to provide information to sponsors of ANDAs on the design of bioequivalence studies for modified-release dosage forms of potassium chloride. A document entitled ‘‘Guidance for In Vivo Bioequivalence Study for SlowRelease Potassium Chloride Tablets/ Capsules’’ was issued on May 15, 1987 (1987 guidance), and revised on June 6, 1994 (1994 revision). The guidance was further revised to incorporate FDA’s current thinking on the bioequivalence requirements for potassium chloride modified-release products and was issued in draft on August 7, 2002 (2002 draft guidance) (67 FR 51284). Comments were reviewed and incorporated. The most substantive changes made are described in the following paragraphs. Editorial changes were also made and the final guidance is now available. In the 2002 draft guidance, the agency recommended a three-way crossover design study comparing the reference listed drug (RLD) to both the generic product and a solution of potassium chloride. The 2002 draft guidance also recommended analysis of covariance (ANCOVA) for the pharmacokinetic parameters. The final guidance provides recommendations for a two-way crossover design comparing the generic PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 product to the RLD. This design is consistent with the 1994 revision, which stated that the potassium chloride solution mentioned in the 1987 guidance was no longer necessary and recommended the use of a twotreatment, two-period, single-dose, fasting study comparing test product with reference product. The FDA determined that the potassium chloride solution arm is not necessary because the objective of the bioequivalence study is to directly compare the rate and extent of potassium absorption from the test product and the reference product. Therefore, the potassium chloride solution arm is not necessary for the test-versus-reference comparison and adds unnecessary complexity to the statistical bioequivalance analysis. We also have decided not to recommend the use of ANCOVA in the final guidance. Analysis of variance (ANOVA) with baseline correction is adequate for bioequivalence analysis of pharmacokinetic data obtained following oral administration of potassium chloride drug products. The FDA concluded that using ANCOVA with baseline as a covariate to analyze baseline-uncorrected data was not as sensitive to changes in formulation performance as using ANOVA to analyze baseline-corrected data. The dissolution testing and criteria for waivers on in vivo testing for lower strengths are revised to reflect the changes outlined in the guidance entitled ‘‘Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations,’’ available on the Internet at https://www.fda.gov/cder/ guidance/index.htm. 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 studies to demonstrate the bioequivalence of potassium chloride modified-release tablets and capsules. 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 guidance at any time. 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 E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 70, Number 206 (Wednesday, October 26, 2005)]
[Notices]
[Pages 61829-61830]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21349]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0392]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Cystic Fibrosis 
Transmembrane Conductance Regulator Gene Mutation Detection Systems; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' 
This guidance document describes a means by which cystic fibrosis 
transmembrane conductance regulator (CFTR) gene mutation detection 
systems may comply with the requirements of special controls for class 
II devices. It includes recommendations for validation of performance 
characteristics and recommendations for product labeling. Elsewhere in 
this issue of the Federal Register, FDA is publishing a final rule to 
classify CFTR gene mutation detection systems into class II (special 
controls). This guidance document is immediately in effect as the 
special control for CFTR gene mutation detection systems, but it 
remains subject to comment in accordance with the agency's good 
guidance practices (GGPs).

DATES: Submit written or electronic comments on this guidance at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: CFTR Gene Mutation Detection Systems'' 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 301-443-8818. 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: Zivana Tezak, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0597.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying CFTR gene mutation detection systems into 
class II (special controls) under section 513(f)(2) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This 
guidance document will serve as the special control for CFTR gene 
mutation detection systems. Section 513(f)(2) of the act provides that 
any person who submits a premarket notification under section 510(k) of 
the act (21 U.S.C. 360(k)) for a device that has not previously been 
classified may, within 30 days after receiving an order classifying the 
device in class III under section 513(f)(1) of the act, request FDA to 
classify the device under the criteria set forth in section 513(a)(1) 
of the act. FDA shall, within 60 days of receiving such a request, 
classify the device by written order. This classification shall be the 
initial classification of the device. Within 30 days after the issuance 
of an order classifying the device, FDA must publish a notice in the 
Federal Register announcing such classification. Because of the 
timeframes established by section 513(f)(2) of the act, FDA has 
determined, under Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)), that it is 
not feasible to allow for public participation before issuing this 
guidance as a final guidance document. Therefore, FDA is issuing this 
guidance document as a level 1 guidance document that is immediately in 
effect. FDA will consider any comments that are received in response to 
this notice to determine whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(Sec.  10.115). The guidance represents the agency's current thinking 
on CFTR gene mutation detection systems. 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

    To receive ``Class II Special Controls Guidance Document: CFTR Gene 
Mutation Detection Systems'' by fax machine, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. Press 1 to enter the system. At the second voice prompt, 
press 1 to order a document. Enter the document number (1564) followed 
by the pound sign (). Follow the remaining voice prompts to 
complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. The Center for Devices and Radiological 
Health (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 contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork

[[Page 61830]]

Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections 
of information addressed in the guidance document have been approved by 
OMB in accordance with the PRA under the regulations governing 
premarket notification submissions (21 CFR part 807, subpart E, OMB 
control number 0910-0120). The labeling provisions addressed in the 
guidance have been approved by OMB under OMB control number 0910-0485.

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 
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: October 17, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-21349 Filed 10-25-05; 8:45 am]
BILLING CODE 4160-01-S

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