Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671), 28043-28045 [2011-11744]
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28043
Federal Register / Vol. 76, No. 93 / Friday, May 13, 2011 / Notices
support them in the requirements
development phase of the acquisition
lifecycle.
• The FFRDC must function so
effectively as to act as an agent for the
sponsor in the design and pursuit of
mission goals.
• The FFRDC must provide rapid
responsiveness to changing
requirements for personnel in all
aspects of strategic, technical and
program management.
• The FFRDC must recognize
government objectives as its own
objectives, partnering with the sponsor
in pursuit of excellence in public
service.
• The FFRDC must allow for nonsponsor, other than CMS, work for
operating Divisions within DHHS.
We are publishing this notice in
accordance with 48 CFR 5.205(b) of the
Federal Acquisition Regulations (FAR),
to enable interested members of the
public to provide comments on this
proposed action. We note that this is the
second of three notices issued under the
FAR.
The Request for Proposal will be
posted on FedBizOpps in the Summer
of 2011. Alternatively, a copy can be
received by contacting the person listed
in the FOR FURTHER INFORMATION
CONTACT section above.
Dated: May 4, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–11708 Filed 5–12–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: OCSE–157 Child Support
Enforcement Program Annual Data
Report.
OMB No.: 0970–0177.
Description: The information obtained
from this form will be used to: (1)
Report Child Support Enforcement
activities to the Congress as required by
law; (2) calculate incentive measures
performance and performance
indicators utilized in the program; and
(3) assist the Office of Child Support
Enforcement (OCSE) in monitoring and
evaluating State Child Support
programs. OCSE is proposing minor
changes to the OCSE–157 report
instructions for medical support line
items that will provide states with the
option to define medical support to
include private health insurance as well
as other health care coverage such as
Medicaid, Children’s Health Insurance
Program (CHIP) and other state coverage
plans, and cash medical support.
Further legislative or regulatory changes
may be necessary to update medical
child support policy.
Respondents: State, Local or Tribal
Government.
ANNUAL BURDEN ESTIMATES
Number of respondents
Number of responses per
respondent
Average burden hours per
response
OCSE–157 .......................................................................................................
54
1
7
378
Estimated Total Annual Burden Hours: ....................................................
........................
........................
........................
378
mstockstill on DSKH9S0YB1PROD with NOTICES
Instrument
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection. The Department
specifically requests comments on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
VerDate Mar<15>2010
17:22 May 12, 2011
Jkt 223001
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–11796 Filed 5–12–11; 8:45 am]
BILLING CODE 4184–01–P
PO 00000
Total burden
hours
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0015]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Orphan Drugs;
Common European Medicines Agency/
Food and Drug Administration
Application Form for Orphan Medicinal
Product Designation (Form FDA 3671)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 13,
2011.
SUMMARY:
Frm 00058
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28044
Federal Register / Vol. 76, No. 93 / Friday, May 13, 2011 / Notices
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0167. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
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:
Orphan Drugs; Common EMA/FDA
Application Form for Orphan
Medicinal Product Designation (Form
FDA 3671)—21 CFR Part 316—(OMB
Control Number 0910–0167)—Extension
Sections 525 through 528 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360aa through
360 dd) give FDA statutory authority to
do the following: (1) Provide
recommendations on investigations
required for approval of marketing
applications for orphan drugs, (2)
designate eligible drugs as orphan
drugs, (3) set forth conditions under
which a sponsor of an approved orphan
drug obtains exclusive approval, and (4)
encourage sponsors to make orphan
drugs available for treatment on an
‘‘open protocol’’ basis before the drug
has been approved for general
marketing. The implementing
regulations for these statutory
requirements have been codified under
part 316 (21 CFR part 316) and specify
procedures that sponsors of orphan
drugs use in availing themselves of the
incentives provided for orphan drugs in
the FD& C Act and sets forth procedures
FDA will use in administering the FD&
C Act with regard to orphan drugs.
Section 316.10 specifies the content and
format of a request for written
recommendations concerning the
nonclinical laboratory studies and
clinical investigations necessary for
approval of marketing applications.
Section 316.12 provides that, before
providing such recommendations, FDA
may require results of studies to be
submitted for review. Section 316.14
contains provisions permitting FDA to
refuse to provide written
recommendations under certain
circumstances. Within 90 days of any
refusal, a sponsor may submit
additional information specified by
FDA. Based on past experience, the FDA
estimates that there will be two
respondents to §§ 316.10, 316.12, and
316.14 requiring 200 hours of human
resources annually.
Section 316.20 specifies the content
and format of an orphan drug
application which includes
requirements that an applicant
document that the disease is rare (affects
fewer than 200,000 persons in the
United States annually) or that the
sponsor of the drug has no reasonable
expectation of recovering costs of
research and development of the drug.
Section 316.21 specifies content of a
request for orphan drug designation
required for verification of orphan-drug
status. Section 316.26 allows an
applicant to amend the applications
under certain circumstances. The
Common European Medicines Agency
(EMA)/FDA Application Form for
Orphan Medicinal Product Designation
(form FDA 3671) 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 the European Union mandated by
the Transatlantic Economic Council.
The FDA does not believe the new form
will result in any increased burden on
the respondents and therefore we
estimate no additional burden. Based on
past experience, FDA estimates there
will be 214 respondents requiring
64,200 hours of human resources
annually. Section 316.22 specifies
requirement of a permanent resident
agent for foreign sponsors. Based on
past experience, FDA estimates 55
respondents requiring 110 hours of
human resources annually. Section
316.27 specifies content of a change in
ownership of orphan-drug designation.
Based on past experience, FDA
estimates 43 respondents requiring 215
hours of human resources annually.
Section 316.30 requires submission of
annual reports, including progress
reports on studies, a description of the
investigational plan, and a discussion of
changes that may affect orphan status.
Based on number of orphan-drug
designations, the number of respondents
is estimated as 1,652 requiring 4,956
hours of human resources annually.
Finally, § 316.36 describes information
required of sponsor when there is
insufficient quantity of approved
orphan drug. Based on past experience,
FDA estimates 1 respondent requiring
45 hours of human resources annually.
The information requested will
provide the basis for an FDA
determination that the drug is for a rare
disease or condition and satisfies the
requirements for obtaining orphan drug
status. Secondly, the information will
describe the medical and regulatory
history of the drug. The respondents to
this collection of information are
biotechnology firms, drug companies,
and academic clinical researchers.
In the Federal Register of January 21,
2011 (76 FR 3910), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
mstockstill on DSKH9S0YB1PROD with NOTICES
21 CFR section and FDA form
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
316.10, 316.12, and 316.14 .................................................
316.20, 316.21, and 316.26 Form FDA 3671 .....................
316.22 ..................................................................................
316.27 ..................................................................................
316.30 ..................................................................................
316.36 ..................................................................................
2
214
55
43
1,652
1
1
2
1
1
1
3
2
428
55
43
1,652
3
100
150
2
5
3
15
200
64,200
110
215
4,956
45
Total ..............................................................................
........................
........................
........................
........................
69,726
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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13MYN1
Federal Register / Vol. 76, No. 93 / Friday, May 13, 2011 / Notices
Dated: May 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2011–11744 Filed 5–12–11; 8:45 am]
BILLING CODE 4160–01–P
[Docket No. FDA–2011–P–0128]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination That XIBROM
(Bromfenac Ophthalmic Solution)
0.09% Was Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
Food and Drug Administration
AGENCY:
[Docket No. FDA–2010–N–0355]
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In the
Federal Register of September 27, 2010
(75 FR 59266), the Agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0606. The
approval expires on February 28, 2014.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
mstockstill on DSKH9S0YB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–11743 Filed 5–12–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:22 May 12, 2011
Jkt 223001
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) has determined
that XIBROM (bromfenac ophthalmic
solution) 0.09% was not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
bromfenac ophthalmic solution 0.09% if
all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
SUMMARY:
PO 00000
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28045
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
XIBROM (bromfenac ophthalmic
solution) 0.09% is the subject of NDA
021664 held by ISTA Pharmaceuticals,
Inc. (Ista), approved March 24, 2005.
XIBROM is a topical nonsteroidal antiinflammatory drug for the treatment of
postoperative inflammation and
reduction of ocular pain in patients who
have undergone cataract extraction.
In a citizen petition dated March 1,
2011, and in a letter dated March 3,
2011, Ista informed FDA that it had
discontinued shipping XIBROM
(bromfenac ophthalmic solution) 0.09%
as of February 28, 2011. Ista took the
position that XIBROM (bromfenac
ophthalmic solution) 0.09% had been
discontinued for safety reasons.
After considering the citizen petition
and reviewing Agency records, FDA
determined under § 314.161 that
XIBROM (bromfenac ophthalmic
solution) 0.09% was not withdrawn for
reasons of safety or effectiveness. We
described the basis for this
determination in our letter response to
Ista’s citizen petition (available on
https://www.regulations.gov under
Docket No. FDA–2011–P–0128).
Accordingly, the Agency will
continue to list XIBROM (bromfenac
ophthalmic solution) 0.09% in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to XIBROM (bromfenac ophthalmic
solution) 0.09% may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Notices]
[Pages 28043-28045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11744]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0015]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Orphan Drugs; Common
European Medicines Agency/Food and Drug Administration Application Form
for Orphan Medicinal Product Designation (Form FDA 3671)
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 June
13, 2011.
[[Page 28044]]
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0167.
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., PI50-400B,
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:
Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal
Product Designation (Form FDA 3671)--21 CFR Part 316--(OMB Control
Number 0910-0167)--Extension
Sections 525 through 528 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360aa through 360 dd) give FDA statutory
authority to do the following: (1) Provide recommendations on
investigations required for approval of marketing applications for
orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set
forth conditions under which a sponsor of an approved orphan drug
obtains exclusive approval, and (4) encourage sponsors to make orphan
drugs available for treatment on an ``open protocol'' basis before the
drug has been approved for general marketing. The implementing
regulations for these statutory requirements have been codified under
part 316 (21 CFR part 316) and specify procedures that sponsors of
orphan drugs use in availing themselves of the incentives provided for
orphan drugs in the FD& C Act and sets forth procedures FDA will use in
administering the FD& C Act with regard to orphan drugs. Section 316.10
specifies the content and format of a request for written
recommendations concerning the nonclinical laboratory studies and
clinical investigations necessary for approval of marketing
applications. Section 316.12 provides that, before providing such
recommendations, FDA may require results of studies to be submitted for
review. Section 316.14 contains provisions permitting FDA to refuse to
provide written recommendations under certain circumstances. Within 90
days of any refusal, a sponsor may submit additional information
specified by FDA. Based on past experience, the FDA estimates that
there will be two respondents to Sec. Sec. 316.10, 316.12, and 316.14
requiring 200 hours of human resources annually.
Section 316.20 specifies the content and format of an orphan drug
application which includes requirements that an applicant document that
the disease is rare (affects fewer than 200,000 persons in the United
States annually) or that the sponsor of the drug has no reasonable
expectation of recovering costs of research and development of the
drug. Section 316.21 specifies content of a request for orphan drug
designation required for verification of orphan-drug status. Section
316.26 allows an applicant to amend the applications under certain
circumstances. The Common European Medicines Agency (EMA)/FDA
Application Form for Orphan Medicinal Product Designation (form FDA
3671) 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 the European Union mandated by the Transatlantic
Economic Council. The FDA does not believe the new form will result in
any increased burden on the respondents and therefore we estimate no
additional burden. Based on past experience, FDA estimates there will
be 214 respondents requiring 64,200 hours of human resources annually.
Section 316.22 specifies requirement of a permanent resident agent for
foreign sponsors. Based on past experience, FDA estimates 55
respondents requiring 110 hours of human resources annually. Section
316.27 specifies content of a change in ownership of orphan-drug
designation. Based on past experience, FDA estimates 43 respondents
requiring 215 hours of human resources annually. Section 316.30
requires submission of annual reports, including progress reports on
studies, a description of the investigational plan, and a discussion of
changes that may affect orphan status. Based on number of orphan-drug
designations, the number of respondents is estimated as 1,652 requiring
4,956 hours of human resources annually. Finally, Sec. 316.36
describes information required of sponsor when there is insufficient
quantity of approved orphan drug. Based on past experience, FDA
estimates 1 respondent requiring 45 hours of human resources annually.
The information requested will provide the basis for an FDA
determination that the drug is for a rare disease or condition and
satisfies the requirements for obtaining orphan drug status. Secondly,
the information will describe the medical and regulatory history of the
drug. The respondents to this collection of information are
biotechnology firms, drug companies, and academic clinical researchers.
In the Federal Register of January 21, 2011 (76 FR 3910), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section and FDA form Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
316.10, 316.12, and 316.14...... 2 1 2 100 200
316.20, 316.21, and 316.26 Form 214 2 428 150 64,200
FDA 3671.......................
316.22.......................... 55 1 55 2 110
316.27.......................... 43 1 43 5 215
316.30.......................... 1,652 1 1,652 3 4,956
316.36.......................... 1 3 3 15 45
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 69,726
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 28045]]
Dated: May 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11744 Filed 5-12-11; 8:45 am]
BILLING CODE 4160-01-P
