Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates, 61495-61497 [2010-25009]
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61495
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
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.
Medical Devices: Recommended
Glossary and Educational Outreach to
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use
(OMB Control Number 0910–0553)—
Extension
Section 502 of the Federal Food, Drug
and Cosmetic Act (the FD&C Act) (21
U.S.C. 352), among other things,
establishes requirements for the label or
labeling of a medical device so that it is
not misbranded. Section 351 of the
Public Health Service Act (the PHS Act)
(42 U.S.C. 262) establishes requirements
that manufacturers of biological
products must submit a license
application for FDA review and
approval prior to marketing a biological
product for introduction into interstate
commerce.
In the Federal Register of November
30, 2004 (69 FR 69606), FDA published
a notice of availability of the guidance
entitled ‘‘Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use.’’
The guidance document provides
guidance for the voluntary use of
selected symbols in place of text in
labeling. It provides the labeling
guidance required for: (1) In vitro
diagnostic devices (IVDs), intended for
professional use under 21 CFR 809.10,
FDA’s labeling requirements for IVDs
and (2) FDA’s labeling requirements for
biologics, including IVDs under 21 CFR
parts 610 and 660. Under section 502(c)
of the FD&C Act, a drug or device is
misbranded, ‘‘* * *If any word,
statement, or other information required
by or under authority of this Act to
appear on the label or labeling is not
prominently placed thereon with such
conspicuousness (as compared with
other words, statements, designs, or
devices, in the labeling) and in such
terms as to render it likely to be read
and understood by the ordinary
individual under customary conditions
of purchase and use.’’
The guidance document recommends
that a glossary of terms accompany each
IVD to define the symbols used on that
device’s labels and/or labeling.
Furthermore, the guidance recommends
an educational outreach effort to
enhance the understanding of newly
introduced symbols. Both the glossary
and educational outreach information
will help to ensure that IVD users will
have enough general familiarity with the
symbols used, as well as provide a quick
reference for available materials, thereby
further ensuring that such labeling
satisfies the labeling requirements under
section 502(c) of the FD&C Act and
section 351 of the PHS Act.
The likely respondents for this
collection of information are IVD
manufacturers who plan to use the
selected symbols in place of text on the
labels and/or labeling of their IVDs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Section 502 of the FD&C
Act/Section 351 of the PHS
Act
No. of
Respondents
Glossary
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1 There
Annual Frequency
per Response
689
Total Annual
Responses
1
Hours per
Response
689
Total Hours
4
2,756
are no capital costs or operating and maintenance costs associated with this collection of information.
The glossary activity is inclusive of
both domestic and foreign IVD
manufacturers. FDA receives
submissions from approximately 689
IVD manufacturers annually. The
number of hours per response for the
glossary and educational outreach
activities were derived from
consultation with a trade association
and FDA personnel. The 4-hour
estimate for a glossary is based on the
average time necessary for a
manufacturer to modify the glossary for
the specific symbols used in labels or
labeling for the IVDs manufactured.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
ACTION:
[FR Doc. 2010–25008 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
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Food and Drug Administration
[Docket No. FDA–2010–N–0161]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Food and
Drug Administration Regulated
Products: Export Certificates
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
4, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0498. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Export of 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) and 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:
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
Certificate 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.
In the Federal Register of March 31,
2010 (75 FR 16137), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
FDA Center
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
mstockstill on DSKH9S0YB1PROD with NOTICES
Center for Biologics Evaluation and
Research
2,114
1
2,114
1
2,114
Center for Drug Evaluation and Research
5,251
1
5,251
2
10,502
Center for Devices and Radiological
Health
6,463
1
6,463
2
12,926
855
1
855
1
855
Center for Veterinary Medicine
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
TABLE 1—TOTAL ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
FDA Center
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Center for Food Safety and Applied Nutrition (Three different product categories)
386
47
11,609
2
23,218
1
337
0.5
169
27,401
50,942
are no capital costs or operating and maintenance costs associated with this collection of information.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0477]
Approval Pathway for Biosimilar and
Interchangeable Biological Products;
Public Hearing; Request for Comments
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
2-day public hearing to obtain input on
specific issues and challenges
associated with the implementation of
the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act). The
BPCI Act establishes an abbreviated
approval pathway for biological
products that are demonstrated to be
‘‘highly similar’’ (biosimilar) to, or
‘‘interchangeable’’ with, an FDAlicensed biological product. The
purpose of this public hearing is to
create a forum for interested
stakeholders to provide input regarding
the agency’s implementation of the
statute. FDA will take the information it
obtains from the public hearing into
account in its implementation of the
BPCI Act.
DATES: The public hearing will be held
November 2 and 3, 2010, from 8:30 a.m.
to 4:30 p.m. Individuals who wish to
present at the public hearing must
register on or before October 11, 2010.
Section III of this document provides
attendance and registration information.
Electronic or written comments will be
accepted after the public hearing until
December 31, 2010.
SUMMARY:
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The public hearing will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Building
31, Rm. 1503, Silver Spring, MD 20993.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Room 1061, Rockville, MD 20852.
Identify comments with the
corresponding docket number found in
brackets in the heading of this
document.
Transcripts of the public hearing will
be available for review at the Division
of Dockets Management and on the
Internet at https://www.regulations.gov
approximately 30 days after the public
hearing (see Section VI of this
document).
A live webcast of this public hearing
will be viewable at the following Web
addresses on the days of the public
hearing: https://www.fda.gov/Drugs/
NewsEvents/ucm221688.htm. A video
record of the public hearing will be
available at the same Web addresses for
1 year.
FOR FURTHER INFORMATION CONTACT:
Sandra J. Benton, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340,
Silver Spring, MD 20993, 301–796–
1042, FAX: 301–847–3529, E-mail:
biosimilarspublicmtg@fda.hhs.gov.
ADDRESSES:
[FR Doc. 2010–25009 Filed 10–4–10; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES
1,158
15,653
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
1.5
337
1 There
772
247
Total
2
SUPPLEMENTARY INFORMATION:
I. Background
On March 23, 2010, President Obama
signed into law the Patient Protection
and Affordable Care Act (Affordable
Care Act) (Pub. L. 111–148). The
Affordable Care Act contains a subtitle
called the Biologics Price Competition
and Innovation Act of 2009 (BPCI Act)
that amends the Public Health Service
Act (PHS Act) and other statutes to
create an abbreviated approval pathway
for biological products shown to be
biosimilar to, or interchangeable with,
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
an FDA-licensed reference biological
product (see sections 7001 through 7003
of the BPCI Act).
The objectives of the BPCI Act are
conceptually similar to those of the
Drug Price Competition and Patent
Term Restoration Act of 1984 (Pub. L.
98–417) (commonly referred to as the
‘‘Hatch-Waxman Act’’), which
established abbreviated pathways for
the approval of drug products under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act). The BPCI Act aligns with
FDA’s longstanding policy of permitting
appropriate reliance on what is already
known about a drug, thereby saving
time and resources and avoiding
unnecessary duplication of human or
animal testing. The implementation of
an abbreviated approval pathway for
biological products can present
challenges given the scientific and
technical complexities that may be
associated with the larger and often
more complex structure of biological
products, as well as the processes by
which such products are manufactured.
Most biological products are produced
in a living system such as a
microorganism, or plant or animal cells,
whereas small molecule drugs are
typically manufactured through
chemical synthesis.
Section 351(k) of the PHS Act (42
U.S.C. 262(k)), added by the BPCI Act,
describes the general requirements for
an application for a proposed biosimilar
biological product and an application or
a supplement for a proposed
interchangeable biological product.
A biological product may be
demonstrated to be ‘‘biosimilar’’ to a
biological reference product based upon
data derived from analytical studies,
animal studies, and a clinical study or
studies if the product is shown to be
highly similar to the reference product,
notwithstanding minor differences in
clinically inactive components, and if
there are no clinically meaningful
differences between the biological
product and the reference product in
terms of safety, purity and potency.
E:\FR\FM\05OCN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61495-61497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25009]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0161]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 4, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0498.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-
[[Page 61496]]
400B, Rockville, MD 20850, 301-796-3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Export of 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) and 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:
------------------------------------------------------------------------
Type of Certificate Use
------------------------------------------------------------------------
``Supplementary Information Certificate For the export of products
to Foreign Government Requests'' legally marketed in the United
``Exporter's Certification Statement States
Certificate to Foreign Government''
``Exporter's Certification Statement
Certificate to Foreign Government (For
Human Tissue Intended for
Transplantation)''
------------------------------------------------------------------------
For the export of products not
``Supplementary Information Certificate approved for marketing in the
of Exportability Requests'' United States (unapproved
``Exporter's Certification Statement products) that meet the
Certificate of Exportability'' requirements of sections
801(e) or 802 of the act
------------------------------------------------------------------------
Conforms to the format
``Supplementary Information Certificate established by the World
of a Pharmaceutical Product'' Health Organization and is
``Exporter's Certification Statement intended for use by the
Certificate of a Pharmaceutical importing country when the
Product'' 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
------------------------------------------------------------------------
For the export of a non-
``Supplementary Information Non- clinical research use only
Clinical Research Use Only product, material, or
Certificate'' component that is not intended
``Exporter's Certification Statement for human use which may be
(Non-Clinical Research Use Only)'' marketed in, and legally
exported from the United
States under the act
------------------------------------------------------------------------
Certificate 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.
In the Federal Register of March 31, 2010 (75 FR 16137), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--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 Biologics Evaluation and Research 2,114 1 2,114 1 2,114
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Drug Evaluation and Research 5,251 1 5,251 2 10,502
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health 6,463 1 6,463 2 12,926
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Veterinary Medicine 855 1 855 1 855
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 61497]]
Center for Food Safety and Applied Nutrition (Three different product categories)
--------------------------------------------------------------------------------------------------------------------------------------------------------
386 2 772 1.5 1,158
--------------------------------------------------------------------------------------------------------------------------------------------------------
247 47 11,609 2 23,218
--------------------------------------------------------------------------------------------------------------------------------------------------------
337 1 337 0.5 169
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 15,653 .................... 27,401 ................. 50,942
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25009 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S
