Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Expander; Availability, 78372-78373 [E8-30440]

Download as PDF 78372 Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Notices SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0603] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Expander; Availability AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Class II Special Controls Guidance Document: Tissue Expander.’’ This draft guidance document describes a means by which the tissue expander device type may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify this device type into class II (special controls). This draft guidance is not final nor is it in effect at this time. 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on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on a final version of the guidance, submit written or electronic comments on the draft guidance by March 23, 2009. ADDRESSES: Submit written requests for single copies of the FDA draft guidance document entitled ‘‘Class II Special Controls Guidance Document: Tissue Expander’’ to the Division of Small Manufacturers, International, and Consumer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 Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 http:// www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Nada Hanafi, Center for Devices and Radiological Health (HFZ–4), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240–276–8848 VerDate Aug<31>2005 19:07 Dec 19, 2008 Jkt 217001 I. Background A tissue expander is a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. It is made of an inflatable silicone elastomer shell filled with Normal Physiological Saline (injection grade). On August 25 and 26, 2005, the General and Plastic Surgery Devices Panel (the Panel) recommended that the tissue expander be classified into class II and that the special control should be a special controls guidance document and labeling. The Panel also considered the types of information the agency should include in a class II special controls guidance document. FDA considered the Panel’s recommendations and, elsewhere in this issue of the Federal Register, FDA is proposing to classify the tissue expander into class II. If this classification rule is finalized, FDA intends that this guidance document will serve as the special control for this device. Following the effective date of any final classification rule based on this proposal, any firm submitting a premarket notification (510(k)) for a tissue expander will need to address the issues covered in the special controls guidance document. However, the firm need only show that its device meets the recommendations of the guidance document or in some other way provides equivalent assurances of safety and effectiveness. II. Significance of Guidance 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 the tissue expander device type. 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 draft guidance may do so by using the Internet. To receive ‘‘Class II Special Controls Guidance Document: Tissue Expander,’’ 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 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 use the document number 1628 to identify the guidance you are requesting. 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 http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at http:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available at http://www.regulations.gov. IV. Paperwork Reduction Act of 1995 This draft 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, have been approved under OMB control no. 0910–0120; the collections of information in 21 CFR part 820 have been approved under OMB control no. 0910–0073; the collections of information in 21 CFR part 812 have been approved under OMB control no. 0910–0078; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control no. 0910–0130; and the collections of information in 21 CFR part 801 have been approved 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 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. Please note that on January 15, 2008, the FDA Division of Dockets E:\FR\FM\22DEN1.SGM 22DEN1 Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Notices Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. Dated: December 16, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–30440 Filed 12–19–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Officer on (301) 443– 1129. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: The Health Professions Student Loan (HPSL) and Nursing Student Loan (NSL) Programs: Forms (OMB No. 0915–0044): Extension The HPSL Program provides longterm, low-interest loans to students Number of respondents Form Responses per respondent 78373 attending schools of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, and pharmacy. The NSL Program provides long-term, lowinterest loans to students who attend eligible schools of nursing in programs leading to a diploma in nursing, and an associate degree, a baccalaureate degree, or a graduate degree in nursing. Participating HPSL and NSL schools are responsible for determining eligibility of applicants, making loans, and collecting monies owed by borrowers on their outstanding loans. The deferment form (HRSA form 519) provides the schools with documentation of a borrower’s eligibility for deferment. The Annual Operating Report (AOR–HRSA form 501) provides the Federal Government with information from participating and non-participating schools (schools that are no longer granting loans but are required to report and maintain program records, student records, and repayment records until all student loans are repaid in full and all monies due the Federal Government are returned) relating to HPSL and NSL program operations and financial activities. The estimate of burden is as follows: Total responses Hours per response Total burden hours Deferment HRSA–519 ..................................... AOR–HRSA–501 ............................................. 2,011 907 1 1 2,011 907 0.166 4 334 3,628 Total ................................................... 2,918 ............................ 2,918 ............................ 3,962 E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: December 15, 2008. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E8–30284 Filed 12–19–08; 8:45 am] mstockstill on PROD1PC66 with NOTICES BILLING CODE 4165–15–P VerDate Aug<31>2005 19:07 Dec 19, 2008 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 instruments, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Officer on (301) 443– 1129. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Faculty Loan Repayment Program (FLRP) Application (OMB No. 0915–0150)— Extension Under the Health Resources and Services Administration (HRSA) Faculty Loan Repayment Program, degree E:\FR\FM\22DEN1.SGM 22DEN1

Agencies

[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Pages 78372-78373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30440]



[[Page 78372]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0603]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: Tissue Expander; 
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Tissue Expander.'' This draft guidance document 
describes a means by which the tissue expander device type may comply 
with the requirement of special controls for class II devices. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
proposed rule to classify this device type into class II (special 
controls). This draft guidance is not final nor is it in effect at this 
time.

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 a final version of the 
guidance, submit written or electronic comments on the draft guidance 
by March 23, 2009.

ADDRESSES:  Submit written requests for single copies of the FDA draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: Tissue Expander'' 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 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 http://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nada Hanafi, Center for Devices and 
Radiological Health (HFZ-4), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8848

SUPPLEMENTARY INFORMATION:

I. Background

    A tissue expander is a device intended for temporary (less than 6 
months) subdermal implantation to stretch the skin for surgical 
applications, specifically to develop surgical flaps and additional 
tissue coverage. It is made of an inflatable silicone elastomer shell 
filled with Normal Physiological Saline (injection grade). On August 25 
and 26, 2005, the General and Plastic Surgery Devices Panel (the Panel) 
recommended that the tissue expander be classified into class II and 
that the special control should be a special controls guidance document 
and labeling. The Panel also considered the types of information the 
agency should include in a class II special controls guidance document. 
FDA considered the Panel's recommendations and, elsewhere in this issue 
of the Federal Register, FDA is proposing to classify the tissue 
expander into class II. If this classification rule is finalized, FDA 
intends that this guidance document will serve as the special control 
for this device.
    Following the effective date of any final classification rule based 
on this proposal, any firm submitting a premarket notification (510(k)) 
for a tissue expander will need to address the issues covered in the 
special controls guidance document. However, the firm need only show 
that its device meets the recommendations of the guidance document or 
in some other way provides equivalent assurances of safety and 
effectiveness.

II. Significance of Guidance

    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 the tissue 
expander device type. 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 draft guidance may do 
so by using the Internet. To receive ``Class II Special Controls 
Guidance Document: Tissue Expander,'' 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 1628 to identify the guidance you are 
requesting.
    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 http://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at http://www.fda.gov/cdrh/
guidance.html. Guidance documents are also available at http://
www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft 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, have been 
approved under OMB control no. 0910-0120; the collections of 
information in 21 CFR part 820 have been approved under OMB control no. 
0910-0073; the collections of information in 21 CFR part 812 have been 
approved under OMB control no. 0910-0078; the collections of 
information in 21 CFR parts 50 and 56 have been approved under OMB 
control no. 0910-0130; and the collections of information in 21 CFR 
part 801 have been approved 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 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.
    Please note that on January 15, 2008, the FDA Division of Dockets

[[Page 78373]]

Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30440 Filed 12-19-08; 8:45 am]
BILLING CODE 4160-01-S