Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products-Export Certificates, 35678-35680 [05-12109]
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Federal Register / Vol. 70, No. 118 / Tuesday, June 21, 2005 / Notices
inherently religious activities can be
found on the HHS Web site at: https://
www.os.dhhs.gov/fbci/waisgate21.pdf
3. Reporting Requirements
Grantees will be required to submit
program progress and financial reports
(SF 269) throughout the project period.
Program progress and financial reports
are due 30 days after the reporting
period. In addition, final programmatic
and financial reports are due 90 days
after the close of the project period.
VII. Agency Contacts
Program Office Contact
Attn: Mary Bruce Webb, ACF, Office
of Planning, Research and Evaluation,
370 L’Enfant Promenade, Washington,
DC 20447. Phone: 202–205–8628.
E-mail: mbwebb@acf.hhs.gov.
Grants Management Office Contact
Attn: Sylvia Johnson, ACF, Division
of Discretionary Grants, 370 L’Enfant
Promenade, Washington, DC 20447.
Phone: 202–260–7622. E-mail:
sjohnson@acf.hhs.gov.
VIII. Other Information
Notice: Beginning with FY 2006, the
Administration for Children and
Families (ACF) will no longer publish
grant announcements in the Federal
Register. Beginning October 1, 2005
applicants will be able to find a
synopsis of all ACF grant opportunities
and apply electronically for
opportunities via: www.Grants.gov.
Applicants will also be able to find the
complete text of all ACF grant
announcements on the ACF Web site
located at: https://www.acf.hhs.gov/
grants/.
Please reference Section IV.3 for
details about acknowledgement of
received applications.
Dated: June 14, 2005.
Mary Bruce Webb,
Senior Research Analyst, ACF/OPRE.
[FR Doc. 05–12157 Filed 6–20–05; 8:45 am]
BILLING CODE 4184–01–P
22:07 Jun 20, 2005
Food and Drug Administration
[Docket No. 2005N–0190]
Program Progress Reports SemiAnnually
Financial Reports: Semi-Annually
VerDate jul<14>2003
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 205001
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 August 22, 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, 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 Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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
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Sfmt 4703
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Export of FDA Regulated Products—
Export Certificates (OMB Control
Number 0910–0498)
In April 1996 a law entitled ‘‘The
FDA Export Reform and Enhancement
Act of 1996’’ 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 act provides that persons exporting
certain FDA-regulated products may
request that FDA certify that the
products meet the requirements of
sections 801(e) or 802 or other
requirements of the act. This section of
the law requires that FDA issue
certification within 20 days of receipt of
the request and 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
pharmaceuticals, biologics, and devices
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)
E:\FR\FM\21JNN1.SGM
21JNN1
35679
Federal Register / Vol. 70, No. 118 / Tuesday, June 21, 2005 / Notices
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
uses:
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, amendment, or review of a license.
‘‘Supplementary Information Nonclinical Research Use Only Certificate’’
‘‘Exporter’s Certification Statement Nonclinical Research Use Only’’
For the export of a nonclinical 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.
Certificates of Free Sale
For food and 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
the previous paragraph. 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. Firms
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
FDA Center
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
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
Center for Devices and Radiological Health
5,674
1
5,674
22
11,348
664
1
664
Center for Veterinary Medicine
Total
1
2
12,642
12,642
There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on center policy that allows multiple devices to appear on one certificate.
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1
664
18,316
35680
Federal Register / Vol. 70, No. 118 / Tuesday, June 21, 2005 / Notices
Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–12109 Filed 6–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0220]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practices and Related
Regulations for Blood and Blood
Components; and Requirements for
Donor Testing, Donor Notification, and
‘‘Lookback’’
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
the information collection requirements
contained in FDA’s current good
manufacturing practice (CGMP) and
related regulations for blood and blood
components; and requirements for
donor testing, donor notification, and
‘‘lookback’’.
Submit written or electronic
comments on the collection of
information by August 22, 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, 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 Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
DATES:
VerDate jul<14>2003
22:07 Jun 20, 2005
Jkt 205001
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Current Good Manufacturing Practices
and Related Regulations for Blood and
Blood Components; and Requirements
for Donor Testing, Donor Notification,
and ‘‘Lookback’’ (OMB Control Number
0910–0116)—Extension
Under the statutory requirements
contained in section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C.
262), no blood, blood component, or
derivative may move in interstate
commerce unless: (1) It is propagated or
manufactured and prepared at an
establishment holding an unsuspended
and unrevoked license; (2) the product
complies with regulatory standards
designed to ensure safety, purity, and
potency; and (3) it bears a label plainly
marked with the product’s proper name,
manufacturer, and expiration date. In
addition, under the biologics licensing
and quarantine provisions in sections
351–361 of the PHS Act (42 U.S.C. 262–
264) and the general administrative
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provisions under sections 501–503,
505–510, and 701–704 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
351–353, 355–360, and 371–374), FDA
has the authority to issue and enforce
regulations designed to protect the
public from unsafe or ineffective
biological products and to issue
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases between States
or possession or from foreign countries
into the States or possession. The CGMP
and related regulations implement
FDA’s statutory authority to ensure the
safety, purity, and potency of blood and
blood components. The ‘‘lookback’’
requirements are intended to help
ensure the continued safety of the blood
supply by providing necessary
information to users of blood and blood
components and appropriate
notification of recipients of transfusion
who are at increased risk for
transmitting human immunodeficiency
virus (HIV) infection. The public health
objective in testing human blood donors
for evidence of infection due to
communicable disease agents and in
donor notification is to prevent the
transmission of communicable disease.
The information collection
requirements in the CGMP, donor
testing, donor notification, and
‘‘lookback’’ regulations provide FDA
with the necessary information to
perform its duty to ensure the safety,
purity, and potency of blood and blood
components. These requirements
establish accountability and traceability
in the processing and handling of blood
and blood components and enables FDA
to conduct meaningful inspections. The
recordkeeping requirements serve
preventative and remedial purposes.
The disclosure requirements identify
the various blood and blood
components and important properties of
the product, demonstrate that the CGMP
requirements have been met, and
facilitate the tracing of a product back
to its original source. The reporting
requirements inform FDA of any
deviations that occur and that may
require immediate corrective action.
Under the reporting requirements,
§ 606.170(b) (21 CFR 606.170(b))
requires that fatal complications of
blood collection and transfusions be
reported to FDA as soon as possible and
that a written report shall be submitted
within 7 days. Section 610.40(c)(1)(ii)
(21 CFR 610.40(c)(1)(ii)) requires each
dedicated donation be labeled as
required under 21 CFR 606.121 and
with a label entitled ‘‘INTENDED
RECIPIENT INFORMATION LABEL’’
containing the name and identifying
information of the recipient. Section
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]]>Agencies
[Federal Register Volume 70, Number 118 (Tuesday, June 21, 2005)]
[Notices]
[Pages 35678-35680]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12109]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0190]
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 August 22, 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, 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 Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Export of FDA Regulated Products--Export Certificates (OMB Control
Number 0910-0498)
In April 1996 a law entitled ``The FDA Export Reform and
Enhancement Act of 1996'' 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 act provides that persons
exporting certain FDA-regulated products may request that FDA certify
that the products meet the requirements of sections 801(e) or 802 or
other requirements of the act. This section of the law requires that
FDA issue certification within 20 days of receipt of the request and
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
pharmaceuticals, biologics, and devices 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)
[[Page 35679]]
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 uses:
Table 1.
----------------------------------------------------------------------------------------------------------------
Type of Certificate Use
----------------------------------------------------------------------------------------------------------------
``Supplementary Information Certificate to Foreign Government For the export of products legally marketed
Requests'' in the United States.
``Exporter's Certification Statement Certificate to Foreign
Government''
``Exporter's Certification Statement Certificate to Foreign
Government (For Human Tissue Intended for Transplantation)''
----------------------------------------------------------------------------------------------------------------
``Supplementary Information Certificate of Exportability For the export of products not approved for
Requests'' marketing in the United States (unapproved
``Exporter's Certification Statement Certificate of products) that meet the requirements of
Exportability'' sections 801(e) or 802 of the act.
----------------------------------------------------------------------------------------------------------------
``Supplementary Information Certificate of a Pharmaceutical Conforms to the format established by the
Product'' World Health Organization and is intended
``Exporter's Certification Statement Certificate of a for use by the importing country when the
Pharmaceutical Product'' product in question is under consideration
for a product license that will authorize
its importation and sale or for renewal,
extension, amendment, or review of a
license.
----------------------------------------------------------------------------------------------------------------
``Supplementary Information Nonclinical Research Use Only For the export of a nonclinical research use
Certificate'' only product, material, or component that is
``Exporter's Certification Statement Nonclinical Research Use not intended for human use which may be
Only'' marketed in, and legally exported from the
United States under the act.
----------------------------------------------------------------------------------------------------------------
Certificates of Free Sale For food and 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 the previous
paragraph. 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. Firms 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.
FDA estimates the burden of this collection of information as
follows:
Table 2.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
FDA Center Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Center for Biologics 1,501 1 1,501 1 1,501
Evaluation and Research
----------------------------------------------------------------------------------------------------------------
Center for Drug Evaluation 4,803 1 4,803 1 4,803
and Research
----------------------------------------------------------------------------------------------------------------
Center for Devices and 5,674 1 5,674 2\2\ 11,348
Radiological Health
----------------------------------------------------------------------------------------------------------------
Center for Veterinary 664 1 664 1 664
Medicine
----------------------------------------------------------------------------------------------------------------
Total 12,642 ................. 12,642 ......... 18,316
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Based on center policy that allows multiple devices to appear on one certificate.
[[Page 35680]]
Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12109 Filed 6-20-05; 8:45 am]
BILLING CODE 4160-01-S
