81 FR 23720 - Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 78 (April 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 78 (April 22, 2016)
| Page Range | 23720-23721 | |
| FR Document | 2016-09368 |
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)] [Notices] [Pages 23720-23721] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09368] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0370] Agency Information Collection Activities; Proposed Collection; 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 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 reporting requirements for firms that intend to export certain unapproved medical devices. DATES: Submit either electronic or written comments on the collection of information by June 21, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N-0370 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be [[Page 23721]] made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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. 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. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Number of Total annual Average burden operating and Activity/section of FD&C Act respondents responses per responses per response Total hours maintenance respondent 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. Dated: April 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09368 Filed 4-21-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices 23721
made publicly available, submit your Colesville Rd., COLE–14526, Silver Export of Medical Devices; Foreign
comments only as a written/paper Spring, MD 20993–0002, PRAStaff@ Letters of Approval—OMB Control
submission. You should submit two fda.hhs.gov. Number 0910–0264—Extension
copies total. One copy will include the
SUPPLEMENTARY INFORMATION: Under the Section 801(e)(2) of the Federal Food,
information you claim to be confidential
PRA (44 U.S.C. 3501–3520), Federal Drug, and Cosmetic Act (the FD&C Act)
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS Agencies must obtain approval from the (21 U.S.C. 381(e)(2)) provides for the
CONFIDENTIAL INFORMATION.’’ The Office of Management and Budget exportation of an unapproved device
Agency will review this copy, including (OMB) for each collection of under certain circumstances if the
the claimed confidential information, in information they conduct or sponsor. exportation is not contrary to the public
its consideration of comments. The ‘‘Collection of information’’ is defined health and safety and it has the approval
second copy, which will have the in 44 U.S.C. 3502(3) and 5 CFR of the foreign country to which it is
claimed confidential information 1320.3(c) and includes Agency requests intended for export. Requesters
redacted/blacked out, will be available or requirements that members of the communicate (either directly or through
for public viewing and posted on http:// public submit reports, keep records, or
a business associate in the foreign
www.regulations.gov. Submit both provide information to a third party.
country) with a representative of the
copies to the Division of Dockets Section 3506(c)(2)(A) of the PRA (44
foreign government to which they seek
Management. If you do not wish your U.S.C. 3506(c)(2)(A)) requires Federal
exportation, and written authorization
name and contact information to be Agencies to provide a 60-day notice in
must be obtained from the appropriate
made publicly available, you can the Federal Register concerning each
office within the foreign government
provide this information on the cover proposed collection of information,
approving the importation of the
sheet and not in the body of your including each proposed extension of an
medical device. An alternative to
comments and you must identify this existing collection of information,
obtaining written authorization from the
information as ‘‘confidential.’’ Any before submitting the collection to OMB
for approval. To comply with this foreign government is to accept a
information marked as ‘‘confidential’’ notarized certification from a
will not be disclosed except in requirement, FDA is publishing notice
of the proposed collection of responsible company official in the
accordance with 21 CFR 10.20 and other United States that the product is not in
applicable disclosure law. For more information set forth in this document.
conflict with the foreign country’s laws.
information about FDA’s posting of With respect to the following
This certification must include a
comments to public dockets, see 80 FR collection of information, FDA invites
statement acknowledging that the
56469, September 18, 2015, or access comments on these topics: (1) Whether
responsible company official making the
the information at: http://www.fda.gov/ the proposed collection of information
certification is subject to the provisions
regulatoryinformation/dockets/ is necessary for the proper performance
of 18 U.S.C. 1001. This statutory
default.htm. of FDA’s functions, including whether
Docket: For access to the docket to the information will have practical provision makes it a criminal offense to
read background documents or the utility; (2) the accuracy of FDA’s knowingly and willingly make a false or
electronic and written/paper comments estimate of the burden of the proposed fraudulent statement, or make or use a
received, go to http:// collection of information, including the false document, in any manner within
www.regulations.gov and insert the validity of the methodology and the jurisdiction of a department or
docket number, found in brackets in the assumptions used; (3) ways to enhance Agency of the United States. The
heading of this document, into the the quality, utility, and clarity of the respondents to this collection of
‘‘Search’’ box and follow the prompts information to be collected; and (4) information are companies that seek to
and/or go to the Division of Dockets ways to minimize the burden of the export medical devices. FDA’s estimate
Management, 5630 Fishers Lane, Rm. collection of information on of the reporting burden is based on the
1061, Rockville, MD 20852. respondents, including through the use experience of FDA’s medical device
FOR FURTHER INFORMATION CONTACT: FDA of automated collection techniques, program personnel.
PRA Staff, Office of Operations, Food when appropriate, and other forms of FDA estimates the burden of this
and Drug Administration, 8455 information technology. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total
Number of Average
Number of Total annual operating and
Activity/section of FD&C Act responses per burden per Total hours
respondents responses maintenance
respondent response 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.
Dated: April 15, 2016.
Leslie Kux,
mstockstill on DSK4VPTVN1PROD with NOTICES
Associate Commissioner for Policy.
[FR Doc. 2016–09368 Filed 4–21–16; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2017-08-22 23:36:48
Document Modified: 2017-08-22 23:36:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by June 21, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 23720 |
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