Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ribonucleic Acid Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and Purification Systems for Real Time Polymerase Chain Reaction Used in Molecular Diagnostic Testing); Availability, 49929-49930 [05-16913]

Download as PDF Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices that the total reporting costs of sponsors would be less than $450,000 annually. Costs could also occur after a marketing application is submitted if FDA determines that the financial interests of an investigator raise significant questions about the integrity of the data. 49929 FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours Per Response Total Hours 1,000 100 46,000 21 CFR Section 1 1 .25 1,000 100 11,500 5 20 .1 5,000 2,000 11,500 18,500 54.4(a)(1) and (a)(2) 54.4(a)(3) 54.4 Total 1There are no capital cost or operating and maintenance costs associated with this collection of information. The sponsors of covered studies will be required to maintain complete records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period of 2 years after the date of approval of the applications. This time is consistent with the current recordkeeping requirements for other information related to marketing applications for human drugs, biologics, and medical devices. Currently, sponsors of covered studies must maintain many records with regard to clinical investigators, including protocol agreements and investigator resumes or curriculum vitae. FDA estimates than an average of 15 minutes will be required for each recordkeeper to add this record to clinical investigators’ file. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours Per Recordkeeper Total Hours 1,000 21 CFR Section 1 1,000 .25 250 250 54.6 Total 1There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 17, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–16915 Filed 8–24–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0264] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ribonucleic Acid Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and Purification Systems for Real Time Polymerase Chain Reaction Used in Molecular Diagnostic Testing); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and VerDate jul<14>2003 15:58 Aug 24, 2005 Jkt 205001 Purification Systems for RT–PCR used in Molecular Diagnostic Testing).’’ This guidance document describes a means by which Ribonucleic Acid (RNA) preanalytical systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify RNA preanalytical systems into class II (special controls). This guidance document is immediately in effect as the special control for RNA preanalytical 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. General comments on agency guidance documents are welcome 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: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT–PCR used in Molecular Diagnostic Testing)’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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 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: Uwe Scherf, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276– 0496. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying RNA preanalytical systems into class II (special controls) under E:\FR\FM\25AUN1.SGM 25AUN1 49930 Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices 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 RNA preanalytical 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 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 GGP regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on RNA preanalytical 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: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT–PCR used in Molecular Diagnostic Testing)’’ by fax call the Center for Devices and Radiological Health (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 (1563) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. To receive ‘‘Class II Special Controls Guidance Document: RNA Preanalytical VerDate jul<14>2003 15:58 Aug 24, 2005 Jkt 205001 Systems (RNA Collection, Stabilization and Purification Systems for RT–PCR used in Molecular Diagnostic Testing),’’ you may either send a fax request to 301–443–8818 to receive a hard copy of the document, or send an e-mail request to gwa@cdrh.fda.gov to receive a hard copy or an electronic copy. Please use the document number (1563) to identify the guidance you are requesting. Persons interested in obtaining a copy of the guidance may also do so by using the Internet. 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 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 written or electronic comments regarding this document to the Division of Dockets Management (see ADDRESSES). 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 9, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–16913 Filed 8–24–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Research and Demonstration Projects for Indian Health AGENCY: Indian Health Service, HHS. ACTION: Notice of single source cooperative agreement with the National Council of Urban Indian Health. SUMMARY: The Indian Health Service (IHS) announces the award of a cooperative agreement to the National Council of Urban Indian Health (NCUIH) for demonstration project for urban Indian health care education, consultation, health care data dissemination, training, and technical assistance to determine the unmet health care needs of urban Indians and to assist the Secretary in assessing the health status and health care of urban Indians. The project is for a three year project period effective September 1, 2005 to August 31, 2008. Annual funding for the project is $417,000. The award is issued under the authority of the Public Health Service Act, Section 301 and the Indian Health Care Improvement Act, Public Law 94– 437, Sections 503, 504, and 511, and is listed under Catalog of Federal Domestic Assistance number 93–933. The specific objectives of the project are: 1. NCUIH will keep the Urban Indian health programs and the IHS informed of items of interest pertaining to the health status and unmet needs of urban Indians and the federal budget process by reviewing activities that have taken place in regard to Indian health care. 2. To disseminate information relative to Title V, local Urban Indian health issues, training opportunities, research instruments, data, budget, NCUIH activities and various forms of technical assistance to the Urban Indian health programs, keeping IHS informed of activities taking place. 3. To disseminate information and respond to all inquiries relative to Title V, local Urban Indian health issues, training opportunities, research instruments, data, budget, NCUIH E:\FR\FM\25AUN1.SGM 25AUN1

Agencies

[Federal Register Volume 70, Number 164 (Thursday, August 25, 2005)]
[Notices]
[Pages 49929-49930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16913]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0264]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Ribonucleic Acid 
Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and 
Purification Systems for Real Time Polymerase Chain Reaction Used in 
Molecular Diagnostic Testing); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: RNA Preanalytical Systems (RNA Collection, 
Stabilization and Purification Systems for RT-PCR used in Molecular 
Diagnostic Testing).'' This guidance document describes a means by 
which Ribonucleic Acid (RNA) preanalytical systems may comply with the 
requirement of special controls for class II devices. Elsewhere in this 
issue of the Federal Register, FDA is publishing a final rule to 
classify RNA preanalytical systems into class II (special controls). 
This guidance document is immediately in effect as the special control 
for RNA preanalytical 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. General comments on agency guidance documents are welcome 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: RNA Preanalytical Systems (RNA Collection, 
Stabilization and Purification Systems for RT-PCR used in Molecular 
Diagnostic Testing)'' 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: Uwe Scherf, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0496.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying RNA preanalytical systems into class II 
(special controls) under

[[Page 49930]]

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 RNA preanalytical 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 GGP regulation 
(21 CFR 10.115). The guidance represents the agency's current thinking 
on RNA preanalytical 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: RNA 
Preanalytical Systems (RNA Collection, Stabilization and Purification 
Systems for RT-PCR used in Molecular Diagnostic Testing)'' by fax call 
the Center for Devices and Radiological Health (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 (1563) followed by the 
pound sign (). Follow the remaining voice prompts to complete 
your request.
    To receive ``Class II Special Controls Guidance Document: RNA 
Preanalytical Systems (RNA Collection, Stabilization and Purification 
Systems for RT-PCR used in Molecular Diagnostic Testing),'' you may 
either send a fax request to 301-443-8818 to receive a hard copy of the 
document, or send an e-mail request to gwa@cdrh.fda.gov to receive a 
hard copy or an electronic copy. Please use the document number (1563) 
to identify the guidance you are requesting.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. 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 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 written or electronic comments 
regarding this document to the Division of Dockets Management (see 
ADDRESSES). 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: August 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-16913 Filed 8-24-05; 8:45 am]
BILLING CODE 4160-01-S

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