Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices-Foreign Letters of Approval, 4086-4087 [2010-1438]

Download as PDF 4086 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices Under table 2, the estimated recordkeeping burden of 1 hour is based on previous estimates for the recordkeeping requirements associated with the AER system. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section 601.91(b)(2)(iii) 1 There 1 [FR Doc. 2010–1439 Filed 1–25–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0031] Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices-Foreign Letters of Approval Food and Drug Administration. Notice. AGENCY: WReier-Aviles on DSKGBLS3C1PROD with NOTICES Total Annual Records 1 Hours per Record 1 Total Hours 1 1 are no capital costs or operating costs associated with this collection of information. Dated: January 20, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. ACTION: Annual Frequency per Recordkeeping 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 written or electronic comments on the collection of information by March 29, 2010. ADDRESSES: Submit electronic comments on the collection of information to https://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. VerDate Nov<24>2008 14:10 Jan 25, 2010 Jkt 220001 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: Daniel Gittleson, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–5156, Daniel.Gittleson@fda.hhs.gov. 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 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 estimates the burden of this collection of information as follows: E:\FR\FM\26JAN1.SGM 26JAN1 4087 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Section of the Federal Food, Drug, and Cosmetic Act 801(e)(2) 1 There 38 Hours per Response 1 38 OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0021. Also include the FDA docket number found in brackets in the heading of this document. Dated: January 20, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–1438 Filed 1–25–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0232] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealers Certificate Food and Drug Administration, HHS. ACTION: Total Annual Responses Total Hours 3 114 are no capital costs or operating and maintenance costs associated with this collection of information. FDA’s estimate of the reporting burden is based on the experience of FDA’s medical device program personnel. AGENCY: Annual Frequency per Response No. of Respondents 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 February 25, 2010. 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, FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793. 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. Interstate Shellfish Dealers Certificate (42 U.S.C. 243) (OMB Control Number 0910–0021)—Extension Under 42 U.S.C. 243, FDA is required to cooperate with and aid State and local authorities in the enforcement of their health regulations and is authorized to assist States in the prevention and suppression of communicable diseases. Under this authority, FDA participates with State regulatory agencies, some foreign nations, and the molluscan shellfish industry in the National Shellfish Sanitation Program (NSSP). NSSP is a voluntary, cooperative program to promote the safety of molluscan shellfish by providing for the classification and patrol of shellfish growing waters and for the inspection and certification of shellfish processors. Each participating State and foreign nation monitors its molluscan shellfish processors and issues certificates for those that meet the State or foreign shellfish control authority’s criteria. Each participating State and nation provides a certificate of its certified shellfish processors to FDA on Form FDA 3038, ‘‘Interstate Shellfish Dealer’s Certificate.’’ FDA uses this information to publish the ‘‘Interstate Certified Shellfish Shippers List,’’ a monthly comprehensive listing of all molluscan shellfish processors certified under the cooperative program. If FDA did not collect the information necessary to compile this list, participating States would not be able to identify and keep out shellfish processed by uncertified processors in other States and foreign nations. Consequently, NSSP would not be able to control the distribution of uncertified and possibly unsafe shellfish in interstate commerce, and its effectiveness would be nullified. In the Federal Register of June 2, 2009 (74 FR 26407), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one letter in response, which contained multiple comments. One comment was generally supportive of the Interstate Certified Shellfish Shippers List program and recommended maintaining the program as it currently exists. Another comment noted that it requires little effort to input information into the form and that the Interstate Shellfish List is critically important to the National Shellfish Sanitation Program. FDA agrees with the comments. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 FDA Form No. Activity WReier-Aviles on DSKGBLS3C1PROD with NOTICES Submission of Interstate Shellfish Dealer’s Certificate 1 There No. of Respondents 3038 Annual Frequency per Response 40 Total Annual Responses 57 Hours per Response 2,280 Total Hours 0.10 are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that 40 respondents will submit 2,280 Interstate Shellfish Dealer’s Certificates annually, for a total burden of 228 hours (2,280 submissions x 0.10 hours = 228 hours). This estimate is based on FDA’s experience and the VerDate Nov<24>2008 14:10 Jan 25, 2010 Jkt 220001 number of certificates received in the past 3 years. PO 00000 Dated: January 20, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–1437 Filed 1–25–10; 8:45 am] BILLING CODE 4160–01–S Frm 00049 Fmt 4703 Sfmt 9990 E:\FR\FM\26JAN1.SGM 26JAN1 228

Agencies

[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Notices]
[Pages 4086-4087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1438]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0031]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Export of Medical Devices-Foreign Letters of Approval

AGENCY: Food and Drug Administration.

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 written or electronic comments on the collection of 
information by March 29, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to https://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: Daniel Gittleson, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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 
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 estimates the burden of this collection of information as 
follows:

[[Page 4087]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Section of the Federal Food, Drug, and Cosmetic                         Annual Frequency      Total Annual          Hours  per
                       Act                         No. of Respondents      per Response          Responses            Response           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
801(e)(2)                                                           38                  1                    38                  3                   114
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of the reporting burden is based on the experience 
of FDA's medical device program personnel.

    Dated: January 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1438 Filed 1-25-10; 8:45 am]
BILLING CODE 4160-01-S
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