[Federal Register Volume 79, Number 140 (Tuesday, July 22, 2014)]
[Notices]
[Pages 42517-42518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16564]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0913]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 513(g) Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
burden estimate for requests for a written statement from FDA regarding 
the classification and regulatory requirements that may be applicable 
to a particular device (513(g) requests).

DATES: Submit either electronic or written comments on the collection 
of information by September 22, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: 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, including 
each proposed extension of an existing 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.

513(g) Request for Information--(OMB Control Number 0910-0705)--
Extension

    Section 513(g) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360c(g)) provides a means for obtaining the 
Agency's views about the classification and regulatory requirements 
that may be applicable to a 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 the FD&C 
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 the FD&C Act applicable to the device.
    The guidance document entitled ``Guidance for Industry and Food and 
Drug Administration Staff FDA and Industry Procedures for Section 
513(g) Requests for Information Under the Federal Food, Drug, and 
Cosmetic Act'' establishes 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 FD&C Act that are submitted in accordance with section 513(g) 
of the FD&C 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 FD&C Act. Additionally, the FD&C Act, as amended by the FDA 
Amendments Act of 2007 (Public Law 110-85), requires FDA to collect 
user fees for 513(g) requests for information. The guidance document 
entitled ``Guidance for Industry and Food and Drug Administration Staff 
User Fees for 513(g) Requests for Information'' assists FDA staff and 
regulated industry by describing the user fees associated with 513(g) 
requests. The Medical Device User Fee Cover Sheet (Form FDA 3601), 
which accompanies the supplemental material described in this 
information collection, is approved under OMB Control No. 0910-0511 and 
expires April 30, 2016.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 42518]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                              Number of       Total       Average
                  Activity                     Number of    responses per     annual     burden per  Total hours
                                              respondents    respondent     responses     response
----------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health            114               1          114           12        1,368
 513(g) requests............................
Center for Biologics Evaluation and Research            4               1            4           12           48
 513(g) requests............................
                                             -------------------------------------------------------------------
    Total...................................  ...........  ..............  ...........  ...........        1,416
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents to this collection of information are mostly device 
manufacturers; however, anyone may submit a 513(g) request for 
information. The total number of annual responses is based on the 
average number of 513(g) requests received each year by the Agency.

    Dated: July 10, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16564 Filed 7-21-14; 8:45 am]
BILLING CODE 4164-01-P