Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice, 44656-44657 [05-15371]

Download as PDF 44656 Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices for Infectious Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 4770 Buford Highway, Mailstop F–22, Atlanta, GA 300341. Telephone: 770–488–3601. E-mail: cxm6@cdc.gov. For financial, grants management, or budget assistance, please contact the following: Jeff Napier, Grants Management Specialist, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770– 488–2614. E-mail: jln1@cdc.gov. VIII. Other Information Other HHS funding opportunity announcements can be found on the HHS/CDC web site, Internet address: https://www.cdc.gov (Click on ‘‘Funding,’’ then ‘‘Grants and Cooperative Agreements’’), and on the HHS Office of Global Health Affairs Web site, Internet address: https:// www.globalhealth.gov (Click on ‘‘What’s new,’’ then ‘‘Funding Opportunities.’’). Dated: July 28, 2005. William P. Nichols, Director, Procurement and Grants Office, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. [FR Doc. 05–15271 Filed 8–2–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0290] Agency Information Collection Activities; Proposed Collection; Comment Request; Importer’s Entry Notice 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 VerDate jul<14>2003 15:22 Aug 02, 2005 Jkt 205001 information collection provisions for the Importer’s Entry Notice. DATES: Submit written or electronic comments on the collection of information by October 3, 2005. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, rm. 1061, 5630 Fishers Lane, 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: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. 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, 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. PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 Importer’s Entry Notice (OMB Control Number 0910–0046)—Extension Section 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381) charges FDA with the following responsibilities: (1) Ensuring that foreign-origin FDA-regulated foods, drugs, cosmetics, medical devices, and radiological health products offered for import into the United States meet the same requirements of the act as do domestic products; and (2) preventing shipments from entering the country if they are not in compliance. The information collected by FDA consists of the following: (1) Product code, an alpha-numeric series of characters that identifies each product FDA regulates; (2) FDA country of origin, the country where the FDAregistered or FDA-responsible firm is located; (3) FDA manufacturer, the party who manufactured, grew, assembled, or otherwise processed the goods (if more than one, the last party who substantially transformed the product); (4) shipper, the party responsible for packing, consolidating, or arranging the shipment of goods to their final destinations; (5) quantity and value of the shipment; and (6) if appropriate, affirmation of compliance, a code that conveys specific FDA information, such as registration number, foreign government certification, etc. This information is collected electronically by the entry filer via the U.S. Customs Service’s Automated Commercial System at he same time he/she files an entry for import with the U.S. Custom Service. FDA uses this information to make admissibility decisions about FDA-regulated products offered for import into the United States. The annual reporting burden is derived from the basic processes and procedures used in fiscal year (FY) 1995. The total number of entries submitted to the automated system in FY 2004 was 6,626,827. The total number of entries less the disclaimer entries will represent the total FDA products entered into the automated system. A total of 53 percent of all entries entered into the automated system were entries dealing with FDAregulated products. The number of respondents is a count of filers who submit entry data for foreign-origin FDA-regulated products. The estimated reporting burden is based on information obtained by FDA contacting some potential respondents. Disclaimer entries are not FDA commodities. FDA estimates the burden for this collection of information as follows: E:\FR\FM\03AUN1.SGM 03AUN1 Federal Register / Vol. 70, No. 148 / Wednesday, August 3, 2005 / Notices 44657 TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Section of the Act 801 3,406 1There Total Annual Responses 1,089 Hours per Response 3,709,134 Total Hours .14 519,279 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 27, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–15371 Filed 8–2–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0564] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Temporary Marketing Permit Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Annual Frequency per Response Notice; correction. 15:22 Aug 02, 2005 Dated: July 27, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–15369 Filed 8–2–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0299] SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 26, 2005 (70 FR 43159). The document announced Office of Management Budget approval for State petitions for exemption from preemption. The document was published with an incorrect title and an incorrect docket number. This document corrects those errors. FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. SUPPLEMENTARY INFORMATION: In FR Doc. 05–14697, appearing on page 43159 in the Federal Register of Tuesday, July 26, 2005, the following corrections are made: 1. On page 43159, in the third column, in the heading of the document, ‘‘[Docket No. 2004N–0565]’’ is corrected to read ‘‘[Docket No. 2004N–0564]’’. 2. On page 43159, in the third column, in the heading of the document, ‘‘Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Petitions for Exemption From Preemption’’ is corrected to read ‘‘Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; VerDate jul<14>2003 Temporary Marketing Permit Applications’’. 3. On page 43159, in the third column, in the SUMMARY section of the document, beginning in the fourth line, ‘‘State Petitions for Exemption From Preemption’’ is corrected to read ‘‘Temporary Marketing Permit Applications’’. Jkt 205001 Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax; Extension; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an extension of the Emergency Use Authorization (EUA) (the Authorization) for Anthrax Vaccine Adsorbed (AVA), issued on January 27, 2005, for prevention of inhalation anthrax for individuals between 18 and 65 years of age who are deemed by the Department of Defense (DoD) to be at heightened risk of exposure due to attack with anthrax. The FDA Commissioner is extending the term of this Authorization on the request of DoD. DATES: The extension of the Authorization was effective as of July 22, 2005. ADDRESSES: Submit written requests for single copies of the extension of the Authorization to the Office of Counterterrorism Policy and Planning (HF–29), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that PO 00000 Frm 00105 Fmt 4703 Sfmt 4703 office in processing your request or include a fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization. FOR FURTHER INFORMATION CONTACT: Boris D. Lushniak, Office of Counterterrorism Policy and Planning (HF–29), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4067. SUPPLEMENTARY INFORMATION: I. Background Section 564 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb–3), as amended by the Project BioShield Act of 2004 (Public Law 108– 276), allows the FDA Commissioner, by delegation from the Secretary of Health and Human Services (the Secretary), to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces. As a result of an October 27, 2004, order by the U.S. District Court for the District of Columbia, the use of AVA by DoD for the prevention of inhalation anthrax is deemed an unapproved use of an approved product for purposes of section 564(a)(2) of the act. On December 10, 2004, under section 564(b)(1)(B) of the act, the Deputy Secretary of Defense determined that there is a significant potential for a military emergency involving a heightened risk to U.S. military forces of attack with anthrax. On December 22, 2004, DoD requested an EUA for AVA for protection against inhalation anthrax. DoD asked for a 6-month authorization and indicated that, if necessary, it might ask for an extension of the duration of the EUA. Under section 564(b) of the act, and on the basis of the Deputy Secretary of Defense’s determination of a significant potential for a military emergency, on January 14, 2005, the Secretary of Health and Human Services, Tommy G. Thompson, declared an emergency justifying the authorization of the emergency use of AVA. Notice of the determination of the Deputy Secretary of Defense and the declaration of the Secretary of Health and Human Services E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 70, Number 148 (Wednesday, August 3, 2005)]
[Notices]
[Pages 44656-44657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0290]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Importer's Entry Notice

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 information collection 
provisions for the Importer's Entry Notice.

DATES: Submit written or electronic comments on the collection of 
information by October 3, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: https://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, rm. 1061, 5630 Fishers Lane, 
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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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, 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.

Importer's Entry Notice (OMB Control Number 0910-0046)--Extension

    Section 801 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 381) charges FDA with the following responsibilities: (1) 
Ensuring that foreign-origin FDA-regulated foods, drugs, cosmetics, 
medical devices, and radiological health products offered for import 
into the United States meet the same requirements of the act as do 
domestic products; and (2) preventing shipments from entering the 
country if they are not in compliance.
    The information collected by FDA consists of the following: (1) 
Product code, an alpha-numeric series of characters that identifies 
each product FDA regulates; (2) FDA country of origin, the country 
where the FDA-registered or FDA-responsible firm is located; (3) FDA 
manufacturer, the party who manufactured, grew, assembled, or otherwise 
processed the goods ( if more than one, the last party who 
substantially transformed the product); (4) shipper, the party 
responsible for packing, consolidating, or arranging the shipment of 
goods to their final destinations; (5) quantity and value of the 
shipment; and (6) if appropriate, affirmation of compliance, a code 
that conveys specific FDA information, such as registration number, 
foreign government certification, etc. This information is collected 
electronically by the entry filer via the U.S. Customs Service's 
Automated Commercial System at he same time he/she files an entry for 
import with the U.S. Custom Service. FDA uses this information to make 
admissibility decisions about FDA-regulated products offered for import 
into the United States.
    The annual reporting burden is derived from the basic processes and 
procedures used in fiscal year (FY) 1995. The total number of entries 
submitted to the automated system in FY 2004 was 6,626,827. The total 
number of entries less the disclaimer entries will represent the total 
FDA products entered into the automated system. A total of 53 percent 
of all entries entered into the automated system were entries dealing 
with FDA-regulated products. The number of respondents is a count of 
filers who submit entry data for foreign-origin FDA-regulated products. 
The estimated reporting burden is based on information obtained by FDA 
contacting some potential respondents. Disclaimer entries are not FDA 
commodities.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 44657]]



                                 TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN\1\
----------------------------------------------------------------------------------------------------------------
 Section of the         No. of        Annual Frequency     Total Annual         Hours per
       Act           Respondents        per Response        Responses           Response          Total Hours
----------------------------------------------------------------------------------------------------------------
 801                          3,406              1,089          3,709,134                 .14            519,279
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: July 27, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-15371 Filed 8-2-05; 8:45 am]
BILLING CODE 4160-01-S
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