Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs, 29515-29517 [E7-10271]
Download as PDF
<![CDATA[
29515
Federal Register / Vol. 72, No. 102 / Tuesday, May 29, 2007 / Notices
In accordance with the provisions of
this notice, we have determined the
amounts of the FY 2004 and FY 2005
redistributed allotment funds to
eliminate the FY 2007 shortfalls in
SCHIP funding available to shortfall
States effective immediately upon
publication of this notice. These FY
2004 and FY 2005 redistributed
allotment funds are subject to final
adjustment based on comments received
in response to this notice.
Authority: (Section 1102 of the Social
Security Act (42 U.S.C. 1302) (Catalog of
Federal Domestic Assistance Program No.
93.767, State Children’s Health Insurance
Program))
Dated: February 16, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Dated: February 26, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 07–2607 Filed 5–25–07; 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
Proposed Projects:
Title: Title V Section 510 Abstinence
Education Grant Program-Annual
Program Application and Annual
Performance Progress Report.
OMB No.: 0970–0271 (formerly 0915–
0291 when in HRSA).
Description: The Title V Section 510
Abstinence Education Grant Program
(Section 510 program) is a formula block
grant program, authorized through June
30, 2007, by the Tax Relief and Health
Care Act of 2006.
The Section 510 Annual Program
Application requires basic application
information that will be used by the
Administration for Children and
Families (ACF) to establish applicant
eligibility, determine each applicant’s
compliance with Federal law, review
and evaluate each applicant’s proposed
plans, and to develop any conditions to
be placed on grant awards. Projects
must meet the legislative priorities as
described in Section 510 of Title V of
the Social Security Act.
The Section 510 Annual Performance
Progress Report includes four forms
through which grantees report basic
performance information, which is used
by ACF to determine each grantee’s
compliance with Federal law and to
review and evaluate each applicant’s
progress toward achieving its goals.
Basic performance information includes
the unduplicated count of clients
served, hours of service received by
clients, program completion data, and
communities served.
Respondents: The 50 States, the
District of Columbia, and the following
8 Territories: American Samoa, Guam,
Republic of the Marshall Islands,
Federated States of Micronesia,
Commonwealth of the Northern Mariana
Islands, Republic of Palau,
Commonwealth of Puerto Rico, and the
U.S. Virgin Islands.
ANNUAL BURDEN ESTIMATES
Number of respondents
Instrument
Number of responses per
respondent
Average burden hours per
response
59
59
1
1
40
130
sroberts on PROD1PC70 with NOTICES
Annual Program Application ............................................................................
Annual Performance Progress Report .............................................................
Estimated Total Annual Burden
Hours: 10,030.
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:
infocolleciotn@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)
VerDate Aug<31>2005
20:45 May 25, 2007
Jkt 211001
Total burden
hours
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 20, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–2628 Filed 5–25–07; 8:45 am]
AGENCY:
2,360
7,670
BILLING CODE 4184–01–M
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Food and Drug Administration
[Docket No. 2006N–0420]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Orphan Drugs
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 28,
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,
E:\FR\FM\29MYN1.SGM
29MYN1
29516
Federal Register / Vol. 72, No. 102 / Tuesday, May 29, 2007 / Notices
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974. 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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857,301–827–
4659.
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 (OMB Control Number
0910–0167)—Extension
Sections 525 through 526 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360aa through
360dd) 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 act and sets forth procedures FDA
will use in administering the act with
regard to orphan drugs. Section 316.10
specifies the content and format of a
request for written recommendations
concerning the non-clinical 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. 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 316.26 allows an applicant to
amend the applications under certain
circumstances. 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. 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.
The information requested from
respondents represents, for the most
part, an accounting of information
already in the possession of the
applicant. It is estimated, based on
frequency of requests over the past 5
years, that 171 persons or organizations
per year will request orphan-drug
designation and none will request
formal recommendations on design of
preclinical or clinical studies.
In the Federal Register of October 30,
2006 (71 FR 63325), FDA published a
60-day notice requesting public
comment on the information collection
provisions. FDA received one comment
related to the information collection.
(Comment 1) The comment suggested
that our burden estimate to prepare an
Orphan Drug Annual Report is too low.
(Response 1) Section 316.30 pertains
to annual reporting, a brief progress
report which is a requirement after
orphan designation has been granted to
a sponsor. We estimate this takes 1 hour
professional time and 1 hour support
time.
(Comment 2) The comment suggested
that our estimate of 130 hours to prepare
and submit an orphan drug application
is too high.
(Response 2) We disagree with the
comment because some sponsors have
more experience with submitting
Orphan Drug Designation applications/
requests and, therefore, may require less
human resource hours to compile all
required information. Many other
sponsors, which include foreign
sponsors, do not have such experience.
The estimated 130 hours pertains to
§§ 316.20, 316.21, and 316.26. These
apply primarily to initial applications/
requests seeking orphan drug
designation. Many applications/requests
received in the Office of Orphan
Products Development contain multiple
volumes; include an exact duplicate
copy of the original; and may include 50
or more documented references.
Additional information is requested
when an application/request is denied.
The sponsor usually supplies the
requested information in the form of an
amendment.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Responses
Total Hours
5
1
5
130
650
316.20, 316.21, & 316.26
171
2
342
130
44,460
316.22
30
1
30
2
60
316.27
25
1
25
4
100
316.30
sroberts on PROD1PC70 with NOTICES
316.10, 316.12, & 316.14
500
1
500
2
1,000
316.36
.2
3
.6
15
9
Total
1 There
46,279
are no capital costs or maintenance costs associated with this collection of information.
VerDate Aug<31>2005
20:45 May 25, 2007
Jkt 211001
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
E:\FR\FM\29MYN1.SGM
29MYN1
Federal Register / Vol. 72, No. 102 / Tuesday, May 29, 2007 / Notices
Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–10271 Filed 5–25–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0193]
Timed-Release Drug Products
Containing Guaifenesin; Enforcement
Action Dates
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
intention to take enforcement action
against unapproved drug products in
timed-release dosage forms containing
guaifenesin and persons who cause the
manufacture or interstate shipment of
such products. Hundreds of unapproved
drug products in timed-release form
containing guaifenesin, alone or in
combination with other ingredients, are
marketed to relieve the symptoms
associated with cough, cold, and similar
conditions. Such drug products require
approved applications because they are
not generally recognized as safe and
effective for these uses. One firm has
obtained approved applications to
market timed-release products
containing guaifenesin. Other firms who
wish to market a drug product in timedrelease form containing guaifenesin
must obtain FDA approval of a new
drug application (NDA) or an
abbreviated new drug application
(ANDA).
This notice is effective May 29,
2007.
For marketed, unapproved drug
products in timed-release form
containing guaifenesin that have a
National Drug Code (NDC) number that
is listed with FDA under section 510 of
the act (21 U.S.C. 360) on the effective
date of this notice (i.e., ‘‘currently
marketed products’’), the agency intends
to exercise its enforcement discretion to
permit products properly marketed with
those NDC numbers a brief period of
continued marketing after May 29, 2007
as follows. FDA does not intend to
initiate enforcement actions against
firms that are manufacturing such
currently marketed products unless
those firms are still manufacturing the
products on or after August 27, 2007.
Further, FDA does not intend to initiate
sroberts on PROD1PC70 with NOTICES
DATES:
VerDate Aug<31>2005
20:45 May 25, 2007
Jkt 211001
enforcement actions related to the
shipment in interstate commerce of
currently marketed products made by
such firms unless they are still being
shipped on or afterNovember 26, 2007.
Unapproved drug products in timedrelease form containing guaifenesin that
are not currently marketed products on
the date of this notice must, as of the
date of this notice, have approved
applications prior to their shipment in
interstate commerce. Submission of an
application does not excuse timely
compliance with this notice.
ADDRESSES: All communications in
response to this notice should be
identified with Docket No. 2007N–0193
and directed to the appropriate office
listed as follows:
Regarding applications under section
505(b) of the act (21 U.S.C. 355(b)):
Division of Pulmonary and Allergy
Products, Office of New Drugs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Silver Spring,
MD 20993–0002.
Regarding applications under section
505(j) of the act: Office of Generic
Drugs, Center for Drug Evaluation and
Research (HFD–600), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855.
All other communications: Sakineh
Walther, Division of New Drugs and
Labeling Compliance, Center for Drug
Evaluation and Research (HFD–310),
Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sakineh Walther, Center for Drug
Evaluation and Research (HFD–310),
Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852,
301–827–8964, e-mail:
sakineh.walther@FDA.HHS.GOV.
SUPPLEMENTARY INFORMATION:
I. Background
Guaifenesin is an expectorant that has
been marketed for decades. Thousands
of products intended to relieve
symptoms associated with cough, colds,
allergies and similar conditions are
marketed containing guaifenesin, alone
or in combination with other active
ingredients, such as antitussives (for
instance, dextromethorphan or
hydrocodone), nasal decongestants (for
instance, pseudoephedrine or
phenylephrine), and analgesics (for
instance, acetaminophen). These
products are marketed both over-thecounter (OTC) and by prescription, and
in immediate- and timed-release dosage
forms.
Guaifenesin in immediate-release
form was reviewed in the OTC drug
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
29517
review and is covered by the OTC
monograph in part 341 (21 CFR part
341), ‘‘Cold, Cough, Allergy,
Bronchodilator, and Antiasthmatic Drug
Products for Over-the-Counter Human
Use.’’ OTC products that comply with
this monograph may be marketed
without approval.
The OTC monograph system does not
include timed-release drug products, a
dosage form that is designed to release
the active ingredients over a prolonged
period of time. Since 1959, the agency
has stated that all products in timedrelease dosage forms also described as,
for example, sustained release, extended
release, controlled release, or longacting—are new drugs requiring
approved applications (24 FR 3756, May
9, 1959). Agency review of individual
applications is needed to ensure that the
finished product releases its active
ingredients at a rate that is both safe,
without ‘‘dumping’’ of the dose, and
effective, sustaining the intended effect
over the entire period during which the
therapeutic benefit is claimed. Firms
submitting applications are required to
establish appropriate release
specifications supported by clinical
evidence, along with data showing that
the finished product as manufactured by
the firm releases its active ingredient
according to these specifications. The
agency’s determination that all products
in timed-release form are new drugs
requiring approved applications is
codified in § 310.502(a)(14) (21 CFR
310.502(a)(14)). The regulation applies
to all products in this dosage form
containing guaifenesin, alone or in
combination with other active
ingredients.
II. Current Status of Timed-Release
Drug Products Containing Guaifenesin
One firm has obtained approved
applications for products in timedrelease dosage forms containing
guaifenesin. Adams Respiratory
Therapeutics, formerly known as Adams
Laboratories, Inc. (Adams), submitted an
NDA for single-ingredient guaifenesin
tablets in timed-release form (NDA 021–
282), which was approved by FDA on
July 12, 2002. These products are sold
OTC under the trade names of
MUCINEX (600 milligrams (mg)) and
HUMIBID (1,200 mg), with labeling for
uses consistent with expectorant
products marketed under an OTC
monograph (§ 341.78(b)). Specifically,
MUCINEX and HUMIBID are intended
to help ‘‘loosen phlegm (mucus) and
thin bronchial secretions to rid the
bronchial passageways of bothersome
mucus, and make coughs more
productive.’’ On October 11, 2002, the
agency notified firms marketing single-
E:\FR\FM\29MYN1.SGM
29MYN1
]]>Agencies
[Federal Register Volume 72, Number 102 (Tuesday, May 29, 2007)]
[Notices]
[Pages 29515-29517]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10271]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0420]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Orphan Drugs
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
28, 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,
[[Page 29516]]
OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. 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 the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,301-827-4659.
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 (OMB Control Number 0910-0167)--Extension
Sections 525 through 526 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360aa through 360dd) 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 act and sets forth procedures FDA will use in
administering the act with regard to orphan drugs. Section 316.10
specifies the content and format of a request for written
recommendations concerning the non-clinical 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. 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 316.26 allows an applicant to amend the
applications under certain circumstances. 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. 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.
The information requested from respondents represents, for the most
part, an accounting of information already in the possession of the
applicant. It is estimated, based on frequency of requests over the
past 5 years, that 171 persons or organizations per year will request
orphan-drug designation and none will request formal recommendations on
design of preclinical or clinical studies.
In the Federal Register of October 30, 2006 (71 FR 63325), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received one comment related to the
information collection.
(Comment 1) The comment suggested that our burden estimate to
prepare an Orphan Drug Annual Report is too low.
(Response 1) Section 316.30 pertains to annual reporting, a brief
progress report which is a requirement after orphan designation has
been granted to a sponsor. We estimate this takes 1 hour professional
time and 1 hour support time.
(Comment 2) The comment suggested that our estimate of 130 hours to
prepare and submit an orphan drug application is too high.
(Response 2) We disagree with the comment because some sponsors
have more experience with submitting Orphan Drug Designation
applications/requests and, therefore, may require less human resource
hours to compile all required information. Many other sponsors, which
include foreign sponsors, do not have such experience.
The estimated 130 hours pertains to Sec. Sec. 316.20, 316.21, and
316.26. These apply primarily to initial applications/requests seeking
orphan drug designation. Many applications/requests received in the
Office of Orphan Products Development contain multiple volumes; include
an exact duplicate copy of the original; and may include 50 or more
documented references. Additional information is requested when an
application/request is denied. The sponsor usually supplies the
requested information in the form of an amendment.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Responses Total Hours
----------------------------------------------------------------------------------------------------------------
316.10, 316.12, & 5 1 5 130 650
316.14
----------------------------------------------------------------------------------------------------------------
316.20, 316.21, & 171 2 342 130 44,460
316.26
----------------------------------------------------------------------------------------------------------------
316.22 30 1 30 2 60
----------------------------------------------------------------------------------------------------------------
316.27 25 1 25 4 100
----------------------------------------------------------------------------------------------------------------
316.30 500 1 500 2 1,000
----------------------------------------------------------------------------------------------------------------
316.36 .2 3 .6 15 9
----------------------------------------------------------------------------------------------------------------
Total .............. ................. ................. ................. 46,279
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance costs associated with this collection of information.
[[Page 29517]]
Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10271 Filed 5-25-07; 8:45 am]
BILLING CODE 4160-01-S
