Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices-Foreign Letters of Approval, 7046-7047 [E7-2489]

Download as PDF 7046 Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section / Form No. 511.1(b)(5)/ Form FDA 3487 Annual Frequency per Response 25 Total Annual Responses2 1.44 Hours per Response 36 .08 Total Hours 2.88 1There are no capital costs or operating and maintenance costs associated with this collection of information. 2Electronic submissions received between July 1, 2005, and June 30, 2006. The number of respondents in Table 1 are the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 2006. (36 x hours per response (.08) = 2.88 total hours). 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: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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: ADDRESSES: Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2485 Filed 2–13–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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 [Docket No. 2006N–0380] 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 March 16, 2007. 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. FDA uses the written authorization from the foreign country or the certification from a responsible company official in the United States to determine whether the foreign country has any objection to the importation of the device into their country. In the Federal Register of September 22, 2006 (71 FR 55487), FDA published a 60-day notice soliciting public comments on the proposed information collection provisions for this requirement. In response to this notice, no comments were received. The agency is also correcting an error. The operating and maintenance cost, which was inadvertently omitted in the burden table for the 60-day notice, has been added as a column to the burden table for this notice. The respondents to this collection of information are companies that seek to export medical devices. FDA estimates the reporting burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section 801(e)2 ycherry on PROD1PC64 with PRELIMS 1There Annual Frequency Per Response No. of Respondents 25 Total Annual Responses 1 Hours per Response Total Hours Total Operating & Maintenance Costs 2.5 62.5 $6,250 25 are no capital costs associated with this collection of information. These estimates are based on the experience of FDA’s medical device program personnel. There are no capital costs associated with this collection of information. In addition, the respondent’s costs of submission of a VerDate Aug<31>2005 17:27 Feb 13, 2007 Jkt 211001 request to the foreign country for approval to import into that country, and subsequent submission of such approval to FDA, vary and are considered operating and maintenance costs. On average, it appears that it can PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 cost a requester approximately $125 per page of translation. From review of our records, it appears that foreign approval letters average two pages. Therefore, the ‘‘other’’ estimated cost to requestors for processing a foreign approval letter is E:\FR\FM\14FEN1.SGM 14FEN1 Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices approximately $6,250 (25 submissions per year x 2 pages = 50 pages x $125 per page = $6,250). Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2489 Filed 2–13–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N -0431] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Evidence of Effectiveness of New Animal Drugs 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. Fax written comments on the collection of information by March 16, 2007. 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: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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: DATES: Substantial Evidence of Effectiveness of New Animal Drugs—21 CFR 514.4(a) (OMB Control Number 0910–0356)— Extension Section 512(d)(1)(E) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(d)(1)(E)), requires FDA to issue an order refusing to approve a new animal drug application (NADA), if there is a lack of substantial evidence that a new animal drug will have the effect it is purported or represented to have under the conditions of use 7047 prescribed in the proposed labeling. Therefore, substantial evidence must be submitted to us as part of the NADA to establish effectiveness of a drug. Section 21 CFR 514.4(a) specifies requirements for submitting adequate and wellcontrolled studies to provide substantial evidence of effectiveness for a new animal drug. This information collection requirement provides for submissions of substantial evidence of effectiveness information via electronic submissions to the Center for Veterinary Medicine (CVM). CVM is continuously seeking ways through advances in information technology to reduce the burden on the government and sponsors. The Center continues to look at what information can be submitted electronically and will permit electronic submission of data to NADA files as technology and resources permit. In the Federal Register of November 2, 2006 (71 FR 64535), FDA published a 60-day notice in the Federal Register soliciting public comment on the proposed collection of information collection requirements. In response to that notice, no comments were received. The likely respondents for this collection of information are sponsors of NADA applications. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 514.4(a) 1There 190 Total Annual Responses 4,546 Hours per Response 860 632.6 Total Hours 544,036 are no capital costs or operating and maintenance costs associated with this collection of information. The estimate for the annual reporting burden for this collection of information was derived from discussion with industry and agency records. Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2497 Filed 2–13–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration ycherry on PROD1PC64 with PRELIMS Annual Frequency per Response Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects VerDate Aug<31>2005 17:27 Feb 13, 2007 Jkt 211001 (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443–1129. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915–0193) Revision The Uniform Data System (UDS) contains the annual reporting requirements for the cluster of primary care grantees funded by the Health Resources and Services Administration (HRSA). The UDS includes reporting requirements for grantees of the following primary care programs: Community Health Centers, Migrant Health Centers, Health Care for the Homeless, Public Housing Primary Care, and other grantees under Section 330. E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7046-7047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2489]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0380]


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 March 
16, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 
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.
    FDA uses the written authorization from the foreign country or the 
certification from a responsible company official in the United States 
to determine whether the foreign country has any objection to the 
importation of the device into their country.
    In the Federal Register of September 22, 2006 (71 FR 55487), FDA 
published a 60-day notice soliciting public comments on the proposed 
information collection provisions for this requirement. In response to 
this notice, no comments were received. The agency is also correcting 
an error. The operating and maintenance cost, which was inadvertently 
omitted in the burden table for the 60-day notice, has been added as a 
column to the burden table for this notice.
    The respondents to this collection of information are companies 
that seek to export medical devices.
    FDA estimates the reporting burden of this collection of 
information as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Annual Frequency     Total Annual       Hours per                 Total Operating &
               21 CFR Section                  No. of Respondents      Per Response        Responses         Response     Total Hours  Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
801(e)2                                                         25                  1                 25             2.5         62.5             $6,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs associated with this collection of information.

    These estimates are based on the experience of FDA's medical device 
program personnel. There are no capital costs associated with this 
collection of information. In addition, the respondent's costs of 
submission of a request to the foreign country for approval to import 
into that country, and subsequent submission of such approval to FDA, 
vary and are considered operating and maintenance costs. On average, it 
appears that it can cost a requester approximately $125 per page of 
translation. From review of our records, it appears that foreign 
approval letters average two pages. Therefore, the ``other'' estimated 
cost to requestors for processing a foreign approval letter is

[[Page 7047]]

approximately $6,250 (25 submissions per year x 2 pages = 50 pages x 
$125 per page = $6,250).

    Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2489 Filed 2-13-07; 8:45 am]
BILLING CODE 4160-01-S
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.