Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates, 76655-76657 [E8-29897]

Download as PDF 76655 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices information as well as the name, address, and phone number of its U.S. agent. Among other uses, this information assists FDA in its inspections of facilities, and its collection is essential to the overall regulatory scheme designed to ensure the safety of the nation’s blood supply. Form FDA 2830 is used to collect this information. Respondents to this collection of information are human blood and plasma donor centers, blood banks, certain transfusion services, other blood product manufacturers, and independent laboratories that engage in quality control and testing for registered blood product establishments. FDA estimates the burden of this collection of information based upon information obtained from FDA’s Center for Biologics Evaluation and Research’s database and FDA experience with the blood establishment registration and product listing requirements. The time needed for industry to complete the Form FDA 2830 is estimated to be 1 hour for new firms. The blood establishments for the most part are familiar with the regulations and registration requirements to fill out this form for the first time. Approximately 111 new Form FDA 2830s are received annually. With annual re-registration of blood establishments, the time needed for industry to complete the Form FDA 2830 is estimated to be 0.5 hours. The blood establishments need only to refer to their files or written instructions for a small portion of the information required. Approximately 2,621 Form FDA 2830s are received annually for reregistration. Approximately 180 Form FDA 2830s are received annually for the product listing update with an estimated average of 0.25 hours to complete the form. In the Federal Register of August 12, 2008 (73 FR 46909), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section Form FDA 2830 607.20(a), 607.21, 607.22, 607.25, and 607.40 Initial Registration 607.21, 607.22, 607.25, 607.26, 607.31, and 607.40 Re-registration 607.21, 607.25, 607.30(a), 607.31, and 607.40 No. of Respondents Product Listing Update Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 111 1 111 1 111 2,621 1 2,621 0.5 1,311 180 1 180 0.25 45 Total 1,467 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 10, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29898 Filed 12–16–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0606] Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES 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 VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 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 requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the act) as amended. DATES: Submit written or electronic comments on the collection of information by February 17, 2009. ADDRESSES: Submit electronic comments on the collection of information to http:// 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. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794. 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\17DEN1.SGM 17DEN1 76656 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices 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 Food and Drug Administration Regulated Products: Export Certificates (OMB Control Number 0910–0498)—Extension In April 1996 a law entitled ‘‘The FDA Export Reform & Enhancement Act of 1996’’ (FDAERA) amended sections 801(e) and 802 of the act (21 U.S.C. 381(e) and 382). It was designed to ease restrictions on exportation of unapproved pharmaceuticals, biologics, and devices regulated by FDA. Section 801(e)(4) of the FDAERA provides that persons exporting certain FDA-regulated products may request FDA to certify that the products meet the requirements of 801(e) or 802 or other requirements of the act. This section of the law requires FDA to issue certification within 20 days of receipt of the request and to charge firms up to $175 for the certifications. This new section of the act authorizes FDA to issue export certificates for regulated pharmaceuticals, biologics, and devices that are legally marketed in the United States, as well as for these same products that are not legally marketed but are acceptable to the importing country, as specified in sections 801(e) and 802 of the act. FDA has developed five types of certificates that satisfy the requirements of section 801(e)(4)(B) of the act: (1) Certificates to Foreign Governments, (2) Certificates of Exportability, (3) Certificates of a Pharmaceutical Product, (4) NonClinical Research Use Only Certificates, and (5) Certificates of Free Sale. Table 1 of this document lists the different certificates and details their use: TABLE 1 Type of Certificate Use ‘‘Supplementary Information Certificate to Foreign Government Requests’’ ‘‘Exporter’s Certification Statement Certificate to Foreign Government’’ ‘‘Exporter’s Certification Statement Certificate to Foreign Government (For Human Tissue Intended for Transplantation)’’ For the export of products legally marketed in the United States ‘‘Supplementary Information Certificate of Exportability Requests’’ ‘‘Exporter’s Certification Statement Certificate of Exportability’’ For the export of products not approved for marketing in the United States (unapproved products) that meet the requirements of sections 801(e) or 802 of the act ‘‘Supplementary Information Certificate of a Pharmaceutical Product’’ ‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical Product’’ Conforms to the format established by the World Health Organization and is intended for use by the importing country when the product in question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or reviewing a license ‘‘Supplementary Information Non-Clinical Research Use Only Certificate’’ ‘‘Exporter’s Certification Statement Non-Clinical Research Use Only’’ For the export of a non-clinical research use only product, material, or component that is not intended for human use which may be marketed in, and legally exported from the United States under the act (5) Certificates of Free Sale For food, cosmetic products, and dietary supplements that may be legally marketed in the United States FDA will continue to rely on selfcertification by manufacturers for the first three types of certificates listed in table 1 of this document. Manufacturers are requested to self-certify that they are in compliance with all applicable requirements of the act, not only at the time that they submit their request to the appropriate center, but also at the time that they submit the certification to the foreign government. The appropriate FDA centers will review product information submitted by firms in support of their certificate and any suspected case of fraud will be referred to FDA’s Office of Criminal Investigations for followup. Making or submitting to FDA false statements on any documents may constitute violations of 18 U.S.C. 1001, with penalties including up to $250,000 in fines and up to 5 years imprisonment. TABLE 2.—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents FDA Center Annual Frequency per Response Total Annual Responses Hours per Response Total Hours pwalker on PROD1PC71 with NOTICES Center for Biologics Evaluation and Research 1,501 1 1,501 1 1,501 Center for Drug Evaluation and Research 4,803 1 4,803 1 4,803 VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\17DEN1.SGM 17DEN1 76657 Federal Register / Vol. 73, No. 243 / Wednesday, December 17, 2008 / Notices TABLE 2.—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1—Continued No. of Respondents FDA Center Center for Devices and Radiological Health 1 6,091 2 12,182 1 664 1 664 5 8,876 2 17,752 14,853 21,935 36,902 are no capital costs or operating and maintenance costs associated with this collection of information. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. Dated: December 10, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29897 Filed 12–16–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0623] Draft Guidance for Industry on Anesthetics for Companion Animals; Availability AGENCY: Total Hours 1,794 Total 1 There Hours per Response 664 Center for Food Safety and Applied Nutrition Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES Total Annual Responses 6,091 Center for Veterinary Medicine ACTION: Annual Frequency per Response Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry #192 entitled ‘‘Anesthetics for Companion Animals.’’ This guidance makes recommendations for the development of anesthetic new animal VerDate Aug<31>2005 18:58 Dec 16, 2008 Jkt 217001 drug products for companion animals. The guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of a new animal drug application (NADA) for general anesthetics. 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 written or electronic comments on the draft guidance by March 2, 2009. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Germaine Connolly, Center for Veterinary Medicine (HFV–116), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276– 8331, e-mail: germaine.connolly@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry #192 entitled ‘‘Anesthetics for Companion Animals.’’ This guidance document makes recommendations to assist developers of general anesthetic drugs (injectable or inhalational) for use in companion animals (dogs, cats, and horses). The guidance specifically describes what should be considered PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 while planning and executing safety and field studies for the proposed anesthetic. In addition, the guidance includes recommendations on how to analyze and package the collected data for submission to the Center for Veterinary Medicine. II. Significance of Guidance This level 1 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 this topic. 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 statutes and regulations. III. 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 collections of information have been approved under OMB control number 0910–0032. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management E:\FR\FM\17DEN1.SGM 17DEN1

Agencies

[Federal Register Volume 73, Number 243 (Wednesday, December 17, 2008)]
[Notices]
[Pages 76655-76657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29897]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0606]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Export of Food and Drug Administration Regulated 
Products: Export Certificates

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 
requirements imposed on firms that intend to export to countries that 
require an export certificate as a condition of entry for FDA regulated 
products, pharmaceuticals, biologics, and devices as indicated in the 
Federal Food, Drug, and Cosmetic Act (the act) as amended.

DATES: Submit written or electronic comments on the collection of 
information by February 17, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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.

[[Page 76656]]

    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 Food and Drug Administration Regulated Products: Export 
Certificates (OMB Control Number 0910-0498)--Extension

    In April 1996 a law entitled ``The FDA Export Reform & Enhancement 
Act of 1996'' (FDAERA) amended sections 801(e) and 802 of the act (21 
U.S.C. 381(e) and 382). It was designed to ease restrictions on 
exportation of unapproved pharmaceuticals, biologics, and devices 
regulated by FDA. Section 801(e)(4) of the FDAERA provides that persons 
exporting certain FDA-regulated products may request FDA to certify 
that the products meet the requirements of 801(e) or 802 or other 
requirements of the act. This section of the law requires FDA to issue 
certification within 20 days of receipt of the request and to charge 
firms up to $175 for the certifications.
    This new section of the act authorizes FDA to issue export 
certificates for regulated pharmaceuticals, biologics, and devices that 
are legally marketed in the United States, as well as for these same 
products that are not legally marketed but are acceptable to the 
importing country, as specified in sections 801(e) and 802 of the act. 
FDA has developed five types of certificates that satisfy the 
requirements of section 801(e)(4)(B) of the act: (1) Certificates to 
Foreign Governments, (2) Certificates of Exportability, (3) 
Certificates of a Pharmaceutical Product, (4) Non-Clinical Research Use 
Only Certificates, and (5) Certificates of Free Sale. Table 1 of this 
document lists the different certificates and details their use:

                                 Table 1
------------------------------------------------------------------------
        Type of Certificate                          Use
------------------------------------------------------------------------
``Supplementary Information          For the export of products legally
 Certificate to Foreign Government    marketed in the United States
 Requests''
``Exporter's Certification
 Statement Certificate to Foreign
 Government''
``Exporter's Certification
 Statement Certificate to Foreign
 Government (For Human Tissue
 Intended for Transplantation)''
------------------------------------------------------------------------
``Supplementary Information          For the export of products not
 Certificate of Exportability         approved for marketing in the
 Requests''                           United States (unapproved
``Exporter's Certification            products) that meet the
 Statement Certificate of             requirements of sections 801(e) or
 Exportability''                      802 of the act
------------------------------------------------------------------------
``Supplementary Information          Conforms to the format established
 Certificate of a Pharmaceutical      by the World Health Organization
 Product''                            and is intended for use by the
``Exporter's Certification            importing country when the product
 Statement Certificate of a           in question is under consideration
 Pharmaceutical Product''             for a product license that will
                                      authorize its importation and sale
                                      or for renewal, extension,
                                      amending, or reviewing a license
------------------------------------------------------------------------
``Supplementary Information Non-     For the export of a non-clinical
 Clinical Research Use Only           research use only product,
 Certificate''                        material, or component that is not
``Exporter's Certification            intended for human use which may
 Statement Non-Clinical Research      be marketed in, and legally
 Use Only''                           exported from the United States
                                      under the act
------------------------------------------------------------------------
(5) Certificates of Free Sale        For food, cosmetic products, and
                                      dietary supplements that may be
                                      legally marketed in the United
                                      States
------------------------------------------------------------------------

    FDA will continue to rely on self-certification by manufacturers 
for the first three types of certificates listed in table 1 of this 
document. Manufacturers are requested to self-certify that they are in 
compliance with all applicable requirements of the act, not only at the 
time that they submit their request to the appropriate center, but also 
at the time that they submit the certification to the foreign 
government.
    The appropriate FDA centers will review product information 
submitted by firms in support of their certificate and any suspected 
case of fraud will be referred to FDA's Office of Criminal 
Investigations for followup. Making or submitting to FDA false 
statements on any documents may constitute violations of 18 U.S.C. 
1001, with penalties including up to $250,000 in fines and up to 5 
years imprisonment.

                              Table 2.--Total Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
  FDA Center       Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Center for                  1,501                     1              1,501                  1              1,501
 Biologics
 Evaluation
 and Research
----------------------------------------------------------------------------------------------------------------
Center for                  4,803                     1              4,803                  1              4,803
 Drug
 Evaluation
 and Research
----------------------------------------------------------------------------------------------------------------

[[Page 76657]]

 
Center for                  6,091                     1              6,091                  2             12,182
 Devices and
 Radiological
 Health
----------------------------------------------------------------------------------------------------------------
Center for                    664                     1                664                  1                664
 Veterinary
 Medicine
----------------------------------------------------------------------------------------------------------------
Center for                  1,794                     5              8,876                  2             17,752
 Food Safety
 and Applied
 Nutrition
----------------------------------------------------------------------------------------------------------------
Total                      14,853  ....................             21,935  .................             36,902
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29897 Filed 12-16-08; 8:45 am]
BILLING CODE 4160-01-S