Agency Emergency Processing Under Office of Management and Budget Review; Orphan Drug Products; Common European Medicines Evaluation Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation, 63615-63616 [E7-21988]
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Federal Register / Vol. 72, No. 217 / Friday, November 9, 2007 / Notices
FDA based these estimates on the
number of inquiries that have been
received concerning the program and
the number of requests for application
forms over the past 3 years.
Dated: November 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–21971 Filed 11–8–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0430]
Agency Emergency Processing Under
Office of Management and Budget
Review; Orphan Drug Products;
Common European Medicines
Evaluation Agency/Food and Drug
Administration Application Form for
Orphan Medicinal Product Designation
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
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 emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). The proposed collection of
information is an amendment to OMB
control number 0910–0167 and
concerns the joint adoption by FDA and
the European Medicines Evaluation
Agency (EMEA) of the Common EMEA/
FDA Application Form for Orphan
Medicinal Product Designation (form
FDA 3671).
DATES: Fax written comments on the
collection of information by November
19, 2007.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number ‘‘0910–0167’’ and the
title, ‘‘Orphan Drug Products; Common
EMEA/FDA Application Form for
Orphan Medicinal Product
Designation.’’ Also include the FDA
docket number found in brackets in the
heading of this document. To obtain a
copy of the draft form FDA 3671, please
call Mary Grice at 301–827–3666 or
VerDate Aug<31>2005
23:48 Nov 08, 2007
Jkt 214001
submit written requests via fax to 301–
827–0017.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: FDA is
requesting emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j) and 5 CFR 1320.13) to
enable the agency to jointly announce
with EMEA the adoption of the
Common EMEA/FDA Application Form
for Orphan Medicinal Product
Designation at the European Union
(EU)-wide Administrative
Simplification Workshop on November
28, 2007. The information is essential to
the agency’s mission of protecting and
promoting the public health. The use of
the normal clearance procedures would
likely result in the prevention or
disruption of this collection of
information.
With respect to the collection of
information, FDA invites comments on
these topics: (1) The clarity and ease of
use of this proposed common
application form; (2) whether the
proposed collection of information is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(3) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(4) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (5) ways to minimize the
burden of the collection of information
on respondents, including the use of
automated collection techniques, when
appropriate, and other forms of
information technology.
Orphan Drug Products; Common
EMEA/FDA Application Form for
Orphan Medicinal Product
Designation—(OMB Congrol Number
0910–0167)—Amendment
This common application form is
intended to benefit sponsors who desire
to seek orphan designation of drugs
intended for rare diseases or conditions
from both the European Commission
and FDA by reducing the burden of
preparing separate applications to meet
the regulatory requirements in each
jurisdiction. It highlights the regulatory
cooperation between the United States
and EU mandated by the Transatlantic
Economic Council (TEC). The TEC
mandate involves: Removal of barriers
to transatlantic commerce; rationalizing,
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
63615
reforming, and, where appropriate,
reducing regulations to empower the
private sector; achieving more effective,
systematic, and transparent regulatory
cooperation to reduce costs associated
with regulation to consumers and
producers; removing unnecessary
differences between jurisdictional
regulations in order to foster economic
integration; reinforcing the existing
transatlantic dialogue structures in
regulatory cooperation, both by
intensifying our sector-by-sector United
States-EU regulatory cooperation and
our dialogue between OMB and the
European Commission services on
methodological issues.
At present, when seeking orphan
designation of the same drug for the
diagnosis, treatment, or prevention of
the same rare disease or condition in the
United States and in the European
Community, a sponsor must submit a
designation request to FDA (in
accordance with section 526 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bb)) and a separate
designation application to EMEA (in
accordance with Regulation (EC) No.
141/2000 of December 16, 1999, and
Commission Regulation (EC) No. 847/
2000). In most cases, the two documents
are formatted differently to meet
regulatory demands, but the required
core information elements are similar
with the exception of some unique
regulatory requirements exclusive to
each jurisdiction. Therefore, FDA and
EMEA believe that a common
application form will help reduce the
sponsor’s regulatory burden and costs to
produce and submit a differentlyformatted request/application. In
addition, a common application form
may also streamline the administrative
and substantive regulatory review
processes, and aid in information
exchange between the agencies. In
accordance with the Confidentiality
Arrangements concluded on September
12, 2003, between the European
Commission, EMEA, and FDA,1 FDA
and EMEA have agreed in principle to
adopt a template for the common
application form as proposed in form
FDA 3671.
Any sponsor seeking orphan
designation of the same drug for the
same disease or condition from both
FDA and EMEA may use this common
application form for regulatory filing
purposes. A sponsor may also use this
common application form when seeking
designation only from FDA. This
1See ‘‘Confidentiality Arrangements Concluded
Between the EU (EC and EMEA) and the US FDA/
DHHS Implementation Plan for Medicinal Products
for Human Use’’ at https://www.fda.gov/oia/
arrangements0904.html.
E:\FR\FM\09NON1.SGM
09NON1
63616
Federal Register / Vol. 72, No. 217 / Friday, November 9, 2007 / Notices
common application form is intended to
complement, not to supersede, the
relevant regulatory frameworks
currently in effect. The sponsor must
comply with all applicable regulatory
requirements in each jurisdiction in
which it seeks designation when using
this common application form.
To use the common application form,
the sponsor must provide the required
information in each applicable section
as instructed in the explanatory notes.
Certain information elements are
identified in the form as required
exclusively by either FDA or EMEA
regulations, and as such they must be
included only in the application to that
jurisdiction. Where additional
explanations and/or supportive
documents are necessary, the sponsor
should sequentially append them at the
end of the common application form in
the order they appear in the form. The
sponsor must also complete the
declaration and signature page. For
FDA, the completed common
application form and required appended
documents must be submitted to the
Office of Orphan Products Development
(HF–35), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. For EMEA, the
completed documents must be
submitted to European Medicines
Agency, 7 Westferry Circus, Canary
Wharf, London E14 4HB, United
Kingdom.
FDA estimates the reporting burden of
this common application form as
follows. Between January 2000 and May
2006, FDA and EMEA received 226
comparable orphan designation
requests/applications of the same drugs
for the same diseases or conditions, or
an average of 35 per year. With the ease
of a common application form, FDA
anticipates the number of such requests/
applications may increase over time.
Therefore, generally there is one
request/application per respondent and
as, at the extreme, all respondent are
U.S.-based, FDA believes up to 40 such
respondents may use the common
application form each year. The
respondents will be primarily
pharmaceutical companies or other forprofit organizations. The collection of
information for sponsors requesting
orphan drug designation from FDA is
currently covered by the Orphan Drug
Regulations (21 CFR Part 316) and
approved under OMB No. 0910–0167
(expires August 31, 2010). For
applications submitted exclusively to
FDA, we do not believe the new form
will result in any increased burden on
the respondents and therefore we
estimate no additional burden for those
respondents. FDA believes the
information required for the EMEA
submission, for the most part, is very
similar to that in the FDA submission,
which is already in the respondents’
possession. The respondents, however,
may have to search existing data sources
or gather additional needed data, such
as on the prevalence or the availability
of alternative methods of diagnosis,
prevention, and treatment of the rare
disease or condition of interest in the
European Community, to complete the
EMEA submission. FDA estimates that it
will take an additional 32 hours (16
hours of professional time and 16 hours
of support time) to compile information
required for the EMEA submission.
Hence, the estimated total annual
human resource hours, at most, would
be 1,280 hours.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual No. of
Respondents
FDA Form No.
FDA 3671
1There
40
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007M–0366]
Medical Devices Regulated by the
Center for Biologics Evaluation and
Research; Availability of Summaries of
Safety and Effectiveness Data for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
Total Annual
Responses
1
Hours per
Response
40
Total Hours
32
1,280
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–21988 Filed 11–8–07; 8:45 am]
ACTION:
Annual Frequency
per Response
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved by the
Center for Biologics Evaluation and
Research (CBER). This list is intended to
VerDate Aug<31>2005
23:48 Nov 08, 2007
Jkt 214001
inform the public of the availability
through the Internet and FDA’s Division
of Dockets Management of summaries of
safety and effectiveness data of
approved PMAs.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please include the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness data.
FOR FURTHER INFORMATION CONTACT:
Pamela Pope, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, suite
200N, 1401 Rockville Pike, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register,
providing instead to post this
information on the Internet at https://
www.fda.gov. In addition, the
regulations provide that FDA publish a
quarterly list of available safety and
effectiveness summaries of PMA
approvals and denials that were
announced during the quarter. FDA
believes that this procedure expedites
public notification of these actions
because announcements can be placed
on the Internet more quickly than they
can be published in the Federal
Register, and FDA believes that the
Internet is accessible to more people
than the Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
E:\FR\FM\09NON1.SGM
09NON1
]]>Agencies
[Federal Register Volume 72, Number 217 (Friday, November 9, 2007)]
[Notices]
[Pages 63615-63616]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21988]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0430]
Agency Emergency Processing Under Office of Management and Budget
Review; Orphan Drug Products; Common European Medicines Evaluation
Agency/Food and Drug Administration Application Form for Orphan
Medicinal Product Designation
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 emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of
information is an amendment to OMB control number 0910-0167 and
concerns the joint adoption by FDA and the European Medicines
Evaluation Agency (EMEA) of the Common EMEA/FDA Application Form for
Orphan Medicinal Product Designation (form FDA 3671).
DATES: Fax written comments on the collection of information by
November 19, 2007.
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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number ``0910-0167'' and the
title, ``Orphan Drug Products; Common EMEA/FDA Application Form for
Orphan Medicinal Product Designation.'' Also include the FDA docket
number found in brackets in the heading of this document. To obtain a
copy of the draft form FDA 3671, please call Mary Grice at 301-827-3666
or submit written requests via fax to 301-827-0017.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: FDA is requesting emergency processing of
this proposed collection of information under section 3507(j) of the
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13) to enable the agency to
jointly announce with EMEA the adoption of the Common EMEA/FDA
Application Form for Orphan Medicinal Product Designation at the
European Union (EU)-wide Administrative Simplification Workshop on
November 28, 2007. The information is essential to the agency's mission
of protecting and promoting the public health. The use of the normal
clearance procedures would likely result in the prevention or
disruption of this collection of information.
With respect to the collection of information, FDA invites comments
on these topics: (1) The clarity and ease of use of this proposed
common application form; (2) whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (3) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (4) ways to enhance the quality, utility, and clarity of the
information to be collected; and (5) ways to minimize the burden of the
collection of information on respondents, including the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Orphan Drug Products; Common EMEA/FDA Application Form for Orphan
Medicinal Product Designation--(OMB Congrol Number 0910-0167)--
Amendment
This common application form is intended to benefit sponsors who
desire to seek orphan designation of drugs intended for rare diseases
or conditions from both the European Commission and FDA by reducing the
burden of preparing separate applications to meet the regulatory
requirements in each jurisdiction. It highlights the regulatory
cooperation between the United States and EU mandated by the
Transatlantic Economic Council (TEC). The TEC mandate involves: Removal
of barriers to transatlantic commerce; rationalizing, reforming, and,
where appropriate, reducing regulations to empower the private sector;
achieving more effective, systematic, and transparent regulatory
cooperation to reduce costs associated with regulation to consumers and
producers; removing unnecessary differences between jurisdictional
regulations in order to foster economic integration; reinforcing the
existing transatlantic dialogue structures in regulatory cooperation,
both by intensifying our sector-by-sector United States-EU regulatory
cooperation and our dialogue between OMB and the European Commission
services on methodological issues.
At present, when seeking orphan designation of the same drug for
the diagnosis, treatment, or prevention of the same rare disease or
condition in the United States and in the European Community, a sponsor
must submit a designation request to FDA (in accordance with section
526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb)) and
a separate designation application to EMEA (in accordance with
Regulation (EC) No. 141/2000 of December 16, 1999, and Commission
Regulation (EC) No. 847/2000). In most cases, the two documents are
formatted differently to meet regulatory demands, but the required core
information elements are similar with the exception of some unique
regulatory requirements exclusive to each jurisdiction. Therefore, FDA
and EMEA believe that a common application form will help reduce the
sponsor's regulatory burden and costs to produce and submit a
differently-formatted request/application. In addition, a common
application form may also streamline the administrative and substantive
regulatory review processes, and aid in information exchange between
the agencies. In accordance with the Confidentiality Arrangements
concluded on September 12, 2003, between the European Commission, EMEA,
and FDA,\1\ FDA and EMEA have agreed in principle to adopt a template
for the common application form as proposed in form FDA 3671.
---------------------------------------------------------------------------
\1\See ``Confidentiality Arrangements Concluded Between the EU
(EC and EMEA) and the US FDA/DHHS Implementation Plan for Medicinal
Products for Human Use'' at https://www.fda.gov/oia/
arrangements0904.html.
---------------------------------------------------------------------------
Any sponsor seeking orphan designation of the same drug for the
same disease or condition from both FDA and EMEA may use this common
application form for regulatory filing purposes. A sponsor may also use
this common application form when seeking designation only from FDA.
This
[[Page 63616]]
common application form is intended to complement, not to supersede,
the relevant regulatory frameworks currently in effect. The sponsor
must comply with all applicable regulatory requirements in each
jurisdiction in which it seeks designation when using this common
application form.
To use the common application form, the sponsor must provide the
required information in each applicable section as instructed in the
explanatory notes. Certain information elements are identified in the
form as required exclusively by either FDA or EMEA regulations, and as
such they must be included only in the application to that
jurisdiction. Where additional explanations and/or supportive documents
are necessary, the sponsor should sequentially append them at the end
of the common application form in the order they appear in the form.
The sponsor must also complete the declaration and signature page. For
FDA, the completed common application form and required appended
documents must be submitted to the Office of Orphan Products
Development (HF-35), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. For EMEA, the completed documents must be
submitted to European Medicines Agency, 7 Westferry Circus, Canary
Wharf, London E14 4HB, United Kingdom.
FDA estimates the reporting burden of this common application form
as follows. Between January 2000 and May 2006, FDA and EMEA received
226 comparable orphan designation requests/applications of the same
drugs for the same diseases or conditions, or an average of 35 per
year. With the ease of a common application form, FDA anticipates the
number of such requests/applications may increase over time. Therefore,
generally there is one request/application per respondent and as, at
the extreme, all respondent are U.S.-based, FDA believes up to 40 such
respondents may use the common application form each year. The
respondents will be primarily pharmaceutical companies or other for-
profit organizations. The collection of information for sponsors
requesting orphan drug designation from FDA is currently covered by the
Orphan Drug Regulations (21 CFR Part 316) and approved under OMB No.
0910-0167 (expires August 31, 2010). For applications submitted
exclusively to FDA, we do not believe the new form will result in any
increased burden on the respondents and therefore we estimate no
additional burden for those respondents. FDA believes the information
required for the EMEA submission, for the most part, is very similar to
that in the FDA submission, which is already in the respondents'
possession. The respondents, however, may have to search existing data
sources or gather additional needed data, such as on the prevalence or
the availability of alternative methods of diagnosis, prevention, and
treatment of the rare disease or condition of interest in the European
Community, to complete the EMEA submission. FDA estimates that it will
take an additional 32 hours (16 hours of professional time and 16 hours
of support time) to compile information required for the EMEA
submission. Hence, the estimated total annual human resource hours, at
most, would be 1,280 hours.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual No. of Annual Frequency Total Annual Hours per
FDA Form No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3671 40 1 40 32 1,280
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21988 Filed 11-8-07; 8:45 am]
BILLING CODE 4160-01-S
