Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems; Availability, 14697-14698 [05-5642]

Download as PDF 14697 Federal Register / Vol. 70, No. 55 / Wednesday, March 23, 2005 / Notices respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: March 17, 2005 Robert Sargis, Reports Clearance Officer. [FR Doc. 05–5687 Filed 3–22–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Children’s Justice Act Program (CJA). OMB No.: 0980–0196. Description: The Program Instruction, prepared in response to the enactment of the Children’s Justice Act (CJA), as set forth in Title II of Pub. L. 108–36, child Abuse Prevention and Treatment Act Amendments of 2003, provides direction to the States and the territories to accomplish the purposes of assisting States in developing, establishing and operating programs designed to improve: (1) The handling of child abuse and neglect cases, particularly child sexual abuse and exploitation, in a manner that limits additional trauma to the child victim; (2) the handling of cases of suspected child abuse or neglect-related fatalities; (3) the investigation and prosecution of cases of child abuse and neglect, particularly child sexual abuse and exploitation; and (4) the handling of cases involving children with disabilities or serious health-related problems who are victims of abuse and neglect. This Program Instruction contains information collection requirements that are found in Pub. L. 108–36 at Sections 107(b) and 107(d), and pursuant to receiving a grant award. The information being collected is required by statute to be submitted pursuant to receiving a grant award. The information submitted will be used by the agency to ensure compliance with the statute; to monitor, evaluate and measure grantee achievements in addressing the investigation and prosecution of child abuse and neglect; and to report to Congress. Respondents: State Governments. ANNUAL BURDEN ESTIMATES Application ....................................................................................... Annual Report .................................................................................. Estimated Total Annual Burden Hours: 3,120. In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: grjohnson@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on VerDate jul<14>2003 16:27 Mar 22, 2005 Jkt 205001 Number of responses per respondent Number of respondents Instrument 52 52 respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: March 16, 2005. Bob Sargis, Reports Clearance Officer. [FR Doc. 05–5688 Filed 3–22–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0082] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration 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 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Average burden hours per response 1 1 40 20 Total burden hours 2,080 1,080 entitled ‘‘Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems.’’ This guidance document describes a means by which automated FISH enumeration systems may comply with the requirements of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify automated FISH enumeration systems into class II (special controls). This guidance document is immediately in effect as the special control for automated FISH enumeration 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: Automated Fluorescence in situ Hybridization (FISH) Enumeration 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 E:\FR\FM\23MRN1.SGM 23MRN1 14698 Federal Register / Vol. 70, No. 55 / Wednesday, March 23, 2005 / Notices 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: Maria M. Chan, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276– 0493, ext. 130. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying automated FISH enumeration 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 automated FISH enumeration 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 written notice 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. VerDate jul<14>2003 16:27 Mar 22, 2005 Jkt 205001 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 automated FISH enumeration 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: Automated Fluorescence in situ Hybridization (FISH) Enumeration 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 (1550) 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. 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 cleared submissions, 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 (44 U.S.C. 3501– 3520). The premarket notification submission provisions addressed in the guidance have been approved by OMB under OMB control number 0910–0120. The labeling provisions addressed in the guidance have been approved by OMB under OMB control number 0910–0485. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: March 10, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–5642 Filed 3–22–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D–0497] Guidance for Industry on Pharmacogenomic Data Submissions; 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 ‘‘Pharmacogenomic Data Submissions.’’ The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug development process, the format of submissions, and how the data will be used in regulatory decisionmaking. The guidance is intended to facilitate scientific progress in the area of pharmacogenomics. DATES: Submit written or electronic comments on agency guidance documents at any time. ADDRESSES: Submit written requests for single copies of the 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 E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 70, Number 55 (Wednesday, March 23, 2005)]
[Notices]
[Pages 14697-14698]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5642]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0082]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Automated Fluorescence in 
situ Hybridization (FISH) Enumeration 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: Automated Fluorescence in situ 
Hybridization (FISH) Enumeration Systems.'' This guidance document 
describes a means by which automated FISH enumeration systems may 
comply with the requirements of special controls for class II devices.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule to classify automated FISH enumeration systems into class 
II (special controls). This guidance document is immediately in effect 
as the special control for automated FISH enumeration 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: Automated Fluorescence in situ Hybridization (FISH) 
Enumeration 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

[[Page 14698]]

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: Maria M. Chan, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0493, ext. 130.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying automated FISH enumeration 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 automated FISH 
enumeration 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 written notice 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 automated FISH enumeration 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: Automated 
Fluorescence in situ Hybridization (FISH) Enumeration 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 (1550) 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. 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 cleared submissions, 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 (44 U.S.C. 3501-3520). The 
premarket notification submission provisions addressed in the guidance 
have been approved by OMB under 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 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: March 10, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-5642 Filed 3-22-05; 8:45 am]
BILLING CODE 4160-01-S

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