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