2010-9937. Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Draft Guidance for Industry and FDA Staff; FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.” This draft guidance is not final nor is it in effect at this time. Elsewhere in this issue of the Federal Register, FDA is also publishing a notice of availability for a draft guidance entitled “Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.”

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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on this draft guidance by July 28, 2010. Submit written or electronic comments on the collection of information by June 28, 2010.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written requests for single copies of the draft guidance document entitled “Draft Guidance for Industry and FDA Staff; FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, or to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this draft guidance and the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD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:

Heather S. Rosecrans, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm., 1532, Silver Spring, MD 20993-0002, 301-796-6571, or Steve Ripley, Center for Biologics Evaluation and Research, (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

Section 513(g) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360c(g) provides a means for obtaining the FDA's views about the classification and the regulatory requirements that may be applicable to a particular device. The purpose of this draft guidance is to establish procedures for submitting, reviewing, and responding to requests for information respecting the class in which a device has been classified or the requirements applicable to a device under the act that are submitted in accordance with section 513(g) of the act. FDA does not review data related to substantial equivalence or safety and effectiveness in a 513(g) Request for Information. FDA's responses to 513(g) Requests for Information are not device classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the act. Additionally, the act, as amended by the FDA Amendments Act of 2007 (FDAAA) (Public Law 110-85), requires FDA to collect user fees for 513(g) Request for Information. Elsewhere in this issue of the Federal Register, FDA is also publishing a notice of availability for a draft guidance entitled “Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.”

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's current thinking on this topic. 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 requirement of the applicable statutes and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Draft Guidance for Industry and FDA Staff; FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act,” you may either send an email request to [e-mail] to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1671 to identify the guidance you are requesting. A search capability for all CDRH guidance documents is available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm or on the CBER Internet site at http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm. Guidance documents are also available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Draft Guidance for Industry and FDA Staff: FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.

Description: Section 513(g) of the act provides a means for obtaining the agency's views about the classification and the regulatory requirements that may be applicable to your particular device. Section 513(g) provides that within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this act, the Secretary of Health and Human Services shall provide such person a written statement of the classification (if any) of such device and the requirements of this act applicable to the device.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden¹

FD&C Act 513(g)	Number of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
CDRH	110	1	110	12	1,320
CBER	4	1	4	12	48
Total					1,368
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA based its estimates on the number of 513(g) Requests for Information received by both CDRH and CBER in 2007-2009. Elsewhere in this issue of the Federal Register, FDA is publishing a document announcing the availability of a draft guidance document entitled “Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.”

This draft guidance also 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. 3501-3502). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR 860.123 have been approved under OMB control number 0910-0138.

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 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.