[Federal Register Volume 72, Number 21 (Thursday, February 1, 2007)]
[Notices]
[Page 4715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1568]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0025]


Guidance for Industry; Class II Special Controls Guidance 
Document: Cord Blood Processing System and Storage Container; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Class II Special Controls 
Guidance Document: Cord Blood Processing System and Storage 
Container.'' The guidance document describes a means by which a cord 
blood processing system and storage container 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 
classifying a cord blood processing system and storage container into 
class II (special controls). This guidance document is immediately in 
effect as the special control for this device, 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 of this 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 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 http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Denise Sanchez, 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

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying a cord blood processing system and storage 
container 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 notice announces the availability of the guidance 
document that will serve as the special control for this device.
    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 into 
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 a 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 or 
appropriate to allow for public participation before issuing this 
guidance as a final guidance document. Thus, 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 the Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
agency's current thinking on a cord blood processing system and storage 
container. 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. 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 807, subpart E (regulations 
governing premarket notification submissions) have been approved under 
OMB Control No. 0910-0120.

IV. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the guidance. 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 the brackets in the heading of this document. A copy of 
the guidance and received comments are available for public examination 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1568 Filed 1-31-07; 8:45 am]
BILLING CODE 4160-01-S