Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices; Availability, 22054-22055 [05-8468]

Download as PDF 22054 Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0010] High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing; Withdrawal AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is withdrawing a notice that published in the Federal Register on January 28, 2005 (70 FR 4134). This notice is being reissued elsewhere in this issue of the Federal Register This notice is withdrawn on April 28, 2005. FOR FURTHER INFORMATION CONTACT: Darlease Hyman, Regulations Policy Management Staff (HF–26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 3480. DATES: In the Federal Register of January 28, 2005 (70 FR 4134), FDA published a notice announcing an opportunity for a hearing on the agency’s proposal to withdraw approval of 13 new drug applications from multiple sponsors. This notice published with an inadvertent error. Therefore, the agency is withdrawing the notice. Elsewhere in this issue of the Federal Register, FDA is reissuing the corrected notice for the convenience of the reader and to give sponsors the fully allotted time to respond. SUPPLEMENTARY INFORMATION: Dated: April 5, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8470 Filed 4–27–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D–0178] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate jul<14>2003 16:00 Apr 27, 2005 Jkt 205001 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.’’ This guidance document describes a means by which class II dental bone grafting material devices may comply with the requirement of special controls. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify tricalcium phosphate (TCP) granules for dental bone repair from class III (premarket approval) to class II (special controls), classify into class II (special controls) other bone grafting material for dental indications, and revise the classification name and identification of the device. 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: Dental Bone Grafting Material Devices’’ 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 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: Michael E. Adjodha, Center for Devices and Radiological Health (HFZ–480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–827–5283, e-mail: michael.adjodha@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 30, 2004 (69 FR 39485), FDA announced the availability of a draft of this special controls guidance document and invited interested persons to comment on it by September 28, 2004. In addition, in the same Federal Register (69 FR 39377), PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 FDA proposed to reclassify tricalcium phosphate (TCP) granules for dental bone repair from class III to class II (special controls). Concurrently, FDA proposed to classify into class II (special controls) all other bone grafting material for dental indications, except those that contained a drug or biologic component; and to revise the classification name and identification of the device. In the proposed rule, FDA identified bone grafting material as a material such as hydroxyapatite, tricalcium phosphate, polylactic acids, or collagen, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. FDA received one comment on the proposed rule and draft special controls guidance document. The comment is addressed in the final rule published elsewhere in this issue of the Federal Register. The final rule published elsewhere in this issue of the Federal Register reclassifies tricalcium phosphate (TCP) granules for dental bone repair from class III (premarket approval) to class II (special controls) and also classifies other dental bone grafting materials that do not contain a drug that is a therapeutic biologic into class II (special controls). Bone grafting material devices that contain a drug that is a therapeutic biologic will remain in class III and continue to require premarket approval. The guidance document provides a means by which the dental bone grafting materials in class II may comply with the requirement of special controls for class II devices. Following the effective date of the final rule, any firm submitting a 510(k) for the class II devices will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. II. Significance of Guidance 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 class II dental bone grafting material devices. 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: Dental Bone Grafting Material Devices’’ by fax, call the CDRH Facts-On-Demand system at E:\FR\FM\28APN1.SGM 28APN1 Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices 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 (1512) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. To receive a hard copy or electronic copy of ‘‘Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices,’’ you may either send a fax request to 301–443– 8818, or send an e-mail request to gwa@cdrh.fda.gov. Please use the document number (1512) 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. 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 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. VerDate jul<14>2003 16:00 Apr 27, 2005 Jkt 205001 Dated: April 4, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–8468 Filed 4–27–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999D–1540] (formerly Docket No. 99D–1540) Guidance for Reviewers on Evaluating the Risks of Drug Exposure in Human Pregnancies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for reviewers entitled ‘‘Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies.’’ This guidance is intended to help FDA staff evaluate human fetal outcome data generated after medical product exposures during pregnancy. The goal of such evaluations is to assist in the development of product labeling that is useful to medical care providers when they care for patients who are pregnant or planning pregnancy. The review of human pregnancy drug exposure data and assessment of fetal risk (or lack of risk) requires consideration of human embryology and teratology, pharmacology, obstetrics, and epidemiology. Consequently, FDA staff also are encouraged to consult with experts in these fields, as appropriate. The guidance announced in this document finalizes the draft guidance entitled ‘‘Guidance for Reviewers: Evaluation of Human Pregnancy Outcome Data’’ announced in the Federal Register of June 4, 1999. DATES: Submit written comments or electronic comments on agency guidances at any time. ADDRESSES: 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, or the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 22055 either office in processing your requests. The guidance may also be obtained by mail by calling the CBER Voice Information System at 1–800–835–4709 or 301–827–1800. 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. FOR FURTHER INFORMATION CONTACT: Dianne L. Kennedy, Center for Drug Evaluation and Research (HFD–020), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–443–5162, e-mail: kennedyd@cder.fda.gov, or Toni M. Stifano, Center for Biologics Evaluation and Research (HFM–602), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301– 827–6190, e-mail: stifano@cber.fda.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for reviewers entitled ‘‘Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies.’’ The guidance provides FDA staff with critical factors to consider when evaluating data on the effects of drug exposure during human pregnancies. It also describes the sources of human data on gestational drug exposures and available resources for more information. The guidance is intended to provide FDA reviewers with a standardized and scientific approach to the evaluation of the effects of human gestational drug exposures. In the Federal Register of June 4, 1999 (64 FR 30040), FDA announced the availability of a draft version of the guidance entitled ‘‘Guidance for Reviewers: Evaluation of Human Pregnancy Outcome Data.’’ When the draft guidance was published, FDA requested comments on the document. Three public comments were received. The comments were supportive of the agency’s efforts to provide this type of guidance. However, the comments also recommended revision/clarification of several sections, as well as provided a number of suggestions of a more technical nature. Additionally, comments regarding the draft guidance raised the following three broader concerns: (1) That it contained redundant information already presented in the guidance for industry entitled ‘‘Establishing Pregnancy Exposure Registries’’ (draft: 64 FR E:\FR\FM\28APN1.SGM 28APN1

Agencies

[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Notices]
[Pages 22054-22055]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8468]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0178]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Dental Bone Grafting 
Material Devices; 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: Dental Bone Grafting Material Devices.'' This 
guidance document describes a means by which class II dental bone 
grafting material devices may comply with the requirement of special 
controls. Elsewhere in this issue of the Federal Register, FDA is 
publishing a final rule to reclassify tricalcium phosphate (TCP) 
granules for dental bone repair from class III (premarket approval) to 
class II (special controls), classify into class II (special controls) 
other bone grafting material for dental indications, and revise the 
classification name and identification of the device.

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: Dental Bone Grafting Material Devices'' 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: Michael E. Adjodha, Center for Devices 
and Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283, e-mail: 
michael.adjodha@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 30, 2004 (69 FR 39485), FDA 
announced the availability of a draft of this special controls guidance 
document and invited interested persons to comment on it by September 
28, 2004. In addition, in the same Federal Register (69 FR 39377), FDA 
proposed to reclassify tricalcium phosphate (TCP) granules for dental 
bone repair from class III to class II (special controls). 
Concurrently, FDA proposed to classify into class II (special controls) 
all other bone grafting material for dental indications, except those 
that contained a drug or biologic component; and to revise the 
classification name and identification of the device. In the proposed 
rule, FDA identified bone grafting material as a material such as 
hydroxyapatite, tricalcium phosphate, polylactic acids, or collagen, 
intended to fill, augment, or reconstruct periodontal or bony defects 
of the oral and maxillofacial region. FDA received one comment on the 
proposed rule and draft special controls guidance document. The comment 
is addressed in the final rule published elsewhere in this issue of the 
Federal Register.
    The final rule published elsewhere in this issue of the Federal 
Register reclassifies tricalcium phosphate (TCP) granules for dental 
bone repair from class III (premarket approval) to class II (special 
controls) and also classifies other dental bone grafting materials that 
do not contain a drug that is a therapeutic biologic into class II 
(special controls). Bone grafting material devices that contain a drug 
that is a therapeutic biologic will remain in class III and continue to 
require premarket approval. The guidance document provides a means by 
which the dental bone grafting materials in class II may comply with 
the requirement of special controls for class II devices.
    Following the effective date of the final rule, any firm submitting 
a 510(k) for the class II devices will need to address the issues 
covered in the special control guidance. However, the firm need only 
show that its device meets the recommendations of the guidance or in 
some other way provides equivalent assurances of safety and 
effectiveness.

II. Significance of Guidance

    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 class II dental bone grafting material 
devices. 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: Dental 
Bone Grafting Material Devices'' by fax, call the CDRH Facts-On-Demand 
system at

[[Page 22055]]

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 (1512) followed by the pound sign 
(). Follow the remaining voice prompts to complete your 
request.
    To receive a hard copy or electronic copy of ``Class II Special 
Controls Guidance Document: Dental Bone Grafting Material Devices,'' 
you may either send a fax request to 301-443-8818, or send an e-mail 
request to gwa@cdrh.fda.gov. Please use the document number (1512) 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. 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 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: April 4, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-8468 Filed 4-27-05; 8:45 am]
BILLING CODE 4160-01-S

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