Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval, 41068-41069 [2013-16408]

Download as PDF 41068 Federal Register / Vol. 78, No. 131 / Tuesday, July 9, 2013 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Omnibus surveys ................................................. 1,200 1 1,200 0.17 (10 minutes) .......... 204 Total (general public) .................................... 8,704 ........................ ........................ ....................................... 1,860 Physician focus group interviews ......................... 144 1 144 1.50 hours ..................... 216 Total (physician) ............................................ 144 ........................ ........................ ....................................... 216 Total (overall) ......................................... 8,848 ........................ ........................ ....................................... 2,076 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 2, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–16401 Filed 7–8–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0370] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by August 8, 2013. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of SUMMARY: Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0264. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, daniel.gittleson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Export of Medical Devices; Foreign Letters of Approval—(OMB Control Number 0910–0264)—Extension Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(e)(2)) provides for the exportation of an unapproved device under certain circumstances if the exportation is not contrary to the public health and safety and it has the approval of the foreign country to which it is intended for export. Requesters communicate (either directly or through a business associate in the foreign country) with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office within the foreign government approving the importation of the medical device. An alternative to obtaining written authorization from the foreign government is to accept a notarized certification from a responsible company official in the United States that the product is not in conflict with the foreign country’s laws. This certification must include a statement acknowledging that the responsible company official making the certification is subject to the provisions of 18 U.S.C. 1001. This statutory provision makes it a criminal offense to knowingly and willingly make a false or fraudulent statement, or make or use a false document, in any manner within the jurisdiction of a department or agency of the United States. The respondents to this collection of information are companies that seek to export medical devices. FDA’s estimate of the reporting burden is based on the experience of FDA’s medical device program personnel. In the Federal Register of April 5, 2013 (78 FR 20660), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 mstockstill on DSK4VPTVN1PROD with NOTICES Activity/section of FD&C Act Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Total operating & maintenance costs Foreign letter of approval—§ 801(e)(2) .... 38 1 38 3 114 $9,500 1 There are no capital costs associated with this collection of information. VerDate Mar<15>2010 17:44 Jul 08, 2013 Jkt 229001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM 09JYN1 Federal Register / Vol. 78, No. 131 / Tuesday, July 9, 2013 / Notices Dated: July 2, 2013. Leslie Kux, Assistant Commissioner for Policy. you are requesting. See the [FR Doc. 2013–16408 Filed 7–8–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Barbara Myklebust, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2312, Silver Spring, MD 20993–0002, 301–796–6005. SUPPLEMENTARY INFORMATION: SUPPLEMENTARY INFORMATION Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Medical Device Reporting for Manufacturers.’’ This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended to update FDA’s policy and to further clarify FDA’s interpretations of the regulation requirements and, when final, will supersede the previous manufacturer guidances issued in 1988 and 1997. This draft guidance also provides answers to frequently asked questions and includes a section on common reporting errors. 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 the final version of the guidance, submit either electronic or written comments on the draft guidance by October 7, 2013. SUMMARY: I. Background Submit written requests for single copies of the draft guidance document entitled ‘‘Medical Device Reporting for Manufacturers’’ 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. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301– 847–8149. Please use the document number 1828 to identify the guidance The first Medical Device Reporting (MDR) regulation became effective December 13, 1984, with mandatory device-related adverse event reporting obligations for manufacturers and importers. FDA published ‘‘Medical Device Reporting Questions and Answers’’ as part of its Compliance Guidance Series in February 1988. Subsequent changes to the reporting requirements, including mandatory reporting by domestic distributors and device user facilities, resulted from amendments to the Federal Food Drug and Cosmetic Act (the FD&C Act) in 1990 and 1992. The MDR regulation was revised significantly after the 1990 and 1992 amendments to the FD&C Act. The amended MDR regulation was published with significant revisions on December 11, 1995, and effective on July 31, 1996. FDA published a guidance document ‘‘Medical Device Reporting for Manufacturers’’ in March 1997 to clarify the changes to reporting requirements under the new regulation. The FD&C Act was further modified by amendments in 1997, 2002, and 2007, requiring further changes to the regulation. A plain language version of the MDR regulation was published on February 28, 2005, effective (in part) on July 13, 2005. This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended to update FDA’s policy and to further clarify FDA’s interpretations of the regulation requirements and, when final, will supersede the previous mstockstill on DSK4VPTVN1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 17:44 Jul 08, 2013 Jkt 229001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 41069 manufacturer guidances issued in 1988 and 1997. The draft guidance also provides answers to frequently asked questions and includes a section on common reporting errors. 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 medical device reporting for manufacturers. 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. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Medical Device Reporting for Manufacturers,’’ 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 301– 847–8149 to receive a hard copy. Please use the document number 1828 to identify the guidance you are requesting. 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 collection of information in 21 CFR part 803 subparts A to E have been approved under OMB 0910–0437 (expires August 31, 2015), and the collection of information in 21 CFR 803.11 and 803.20 have been approved under OMB control number 0910–0291 (expires June 30, 2015). V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management. It is necessary to send only one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be E:\FR\FM\09JYN1.SGM 09JYN1

Agencies

[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41068-41069]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16408]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0370]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export of Medical
Devices; Foreign Letters of Approval

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August
8, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0264.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Export of Medical Devices; Foreign Letters of Approval--(OMB Control
Number 0910-0264)--Extension

Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 381(e)(2)) provides for the exportation of an
unapproved device under certain circumstances if the exportation is not
contrary to the public health and safety and it has the approval of the
foreign country to which it is intended for export. Requesters
communicate (either directly or through a business associate in the
foreign country) with a representative of the foreign government to
which they seek exportation, and written authorization must be obtained
from the appropriate office within the foreign government approving the
importation of the medical device. An alternative to obtaining written
authorization from the foreign government is to accept a notarized
certification from a responsible company official in the United States
that the product is not in conflict with the foreign country's laws.
This certification must include a statement acknowledging that the
responsible company official making the certification is subject to the
provisions of 18 U.S.C. 1001. This statutory provision makes it a
criminal offense to knowingly and willingly make a false or fraudulent
statement, or make or use a false document, in any manner within the
jurisdiction of a department or agency of the United States. The
respondents to this collection of information are companies that seek
to export medical devices. FDA's estimate of the reporting burden is
based on the experience of FDA's medical device program personnel.
In the Federal Register of April 5, 2013 (78 FR 20660), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total operating
Activity/section of FD&C Act Number of responses per Total annual Average burden Total hours & maintenance
respondents respondent responses per response costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign letter of approval--Sec. 801(e)(2)...... 38 1 38 3 114 $9,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

[[Page 41069]]

Dated: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16408 Filed 7-8-13; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.