Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review, 75564-75565 [2014-29607]
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Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices
9.2.4.8 Authorized Persons To Pick Up
Child
Children may only be released to
adults authorized by parents or legal
guardians and whose identity has been
verified by photo identification. Names,
addresses, and telephone numbers of
persons authorized to take a child under
care out of the facility should be
obtained during the enrollment process
and regularly reviewed, along with
clarification/documentation of any
custody issues/court orders. The legal
guardian(s) of the child should be
established and documented at this
time.
9.4.1.12 Record of Valid License,
Certificate, or Registration of Facility
Every facility should hold a valid
license, certificate, or documentation of
registration prior to operation as
required by the local and/or state
statute.
mstockstill on DSK4VPTVN1PROD with NOTICES
9.4.2.1 Contents of Child Records
Programs should maintain a
confidential file for each child in one
central location on-site and should be
immediately available to the child’s
caregivers/teachers (who should have
parental/guardian consent for access to
records), the child’s parents/guardians,
and the licensing authority upon
request. The file for each child should
include the following:
(a) Pre-admission enrollment
information;
(b) Admission agreement signed by
the parent/guardian at enrollment;
(c) Initial and updated health care
assessments, completed and signed by
the child’s primary care provider, based
on the child’s most recent well care
visit;
(d) Health history completed by the
parent/guardian at admission;
(e) Medication record;
(f) Authorization form for emergency
medical care;
(g) Written informed consent forms
signed by the parent/guardian allowing
the facility to share the child’s health
records with other service providers.
10.4.2.1 Frequency of Inspections for
Child Care Centers, Large Family Child
Care Homes, and Small Family Child
Care Homes
The licensing inspector or monitoring
staff should make an onsite inspection
to measure compliance with licensing/
regulatory rules prior to issuing an
initial license and at least two
inspections each year to each center and
large and small family child care home
thereafter. At least one of the
inspections should be unannounced,
and more if they are needed for the
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facility to achieve satisfactory
compliance or if the facility is closed at
any time. Sufficient numbers of
licensing inspectors should be hired to
provide adequate time visiting and
inspecting programs to ensure
compliance with regulations.
The number of inspections should not
include those inspections conducted for
the purpose of investigating complaints.
Complaints should be investigated
promptly, based on severity of the
complaint. States are encouraged to post
the results of licensing inspections,
including complaints, on the Internet
for parent and public review. Parents/
guardians should be provided easy
access to the licensing rules and made
aware of how to report complaints to the
licensing agency.
Dated: December 12, 2014.
Linda K. Smith,
Deputy Assistant Secretary for Early
Childhood Development, Administration for
Children and Families, U.S. Department of
Health and Human Services.
[FR Doc. 2014–29649 Filed 12–17–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0996]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry: Fast Track Drug
Development Programs: Designation,
Development, and Application Review
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 January 20,
2015.
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 0910–0389. Also
SUMMARY:
PO 00000
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include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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.
Guidance for Industry: Fast Track Drug
Development Programs: Designation,
Development, and Application
Review—(OMB Control Number 0910–
0389)—Extension
Section 112(a) of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by adding
section 506 (21 U.S.C. 356). The section
authorizes FDA to take appropriate
action to facilitate the development and
expedite the review of new drugs,
including biological products, intended
to treat a serious or life-threatening
condition and that demonstrate a
potential to address an unmet medical
need. Under section 112(b) of FDAMA,
FDA issued guidance to industry on fast
track policies and procedures outlined
in section 506 of the FD&C Act. The
guidance discusses collections of
information that are specified under
section 506 of the FD&C Act, other
sections of the Public Health Service
Act (the PHS Act), or implementing
regulations. The guidance describes
three general areas involving the
collection of information: (1) Fast track
designation requests, (2) premeeting
packages, and (3) requests to submit
portions of an application. Of these, fast
track designation requests and
premeeting packages, in support of
receiving a fast track program benefit,
provide for additional collections of
information not covered elsewhere in
statute or regulation. Information in
support of fast track designation or fast
track program benefits that has
previously been submitted to the
Agency, may, in some cases, be
incorporated into the request by
referring to the information rather than
resubmitting it.
Under section 506(a)(1) of the FD&C
Act, an applicant who seeks fast track
designation is required to submit a
request to the Agency showing that the
drug product: (1) Is intended for a
serious or life-threatening condition and
(2) has the potential to address an
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Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices
unmet medical need. The Agency
expects that information to support a
designation request will have been
gathered under existing provisions of
the FD&C Act, the PHS Act, or the
implementing regulations. If such
information has already been submitted
to the Agency, the information may be
summarized in the fast track designation
request. The guidance recommends that
a designation request include, where
applicable, additional information not
specified elsewhere by statute or
regulation. For example, additional
information may be needed to show that
a product has the potential to address an
unmet medical need where an approved
therapy exists for the serious or lifethreatening condition to be treated.
Such information may include clinical
data, published reports, summaries of
data and reports, and a list of references.
The amount of information and
discussion in a designation request need
not be voluminous, but it should be
sufficient to permit a reviewer to assess
whether the criteria for fast track
designation have been met.
After the Agency makes a fast track
designation, a sponsor or applicant may
submit a premeeting package that may
include additional information
supporting a request to participate in
certain fast track programs. The
premeeting package serves as
background information for the meeting
and should support the intended
objectives of the meeting. As with the
request for fast track designation, the
Agency expects that most sponsors or
applicants will have gathered such
information to meet existing
requirements under the FD&C Act, the
PHS Act, or implementing regulations.
These may include descriptions of
clinical safety and efficacy trials not
conducted under an investigational new
drug application (i.e., foreign studies)
and information to support a request for
accelerated approval. If such
information has already been submitted
to FDA, the information may be
summarized in the premeeting package.
Consequently, FDA anticipates that the
additional collection of information
attributed solely to the guidance will be
minimal.
Under section 506(c) of the FD&C Act,
a sponsor must submit sufficient
clinical data for the Agency to
determine, after preliminary evaluation,
that a fast track product may be
effective. Section 506(c) also requires
that an applicant provide a schedule for
the submission of information necessary
to make the application complete before
FDA can commence its review. The
guidance does not provide for any new
collection of information regarding the
submission of portions of an application
that are not required under section
506(c) of the FD&C Act or any other
provision of the FD&C Act.
All forms referred to in the guidance
have current OMB approval: Forms FDA
1571 (OMB control number 0910–0014),
356h (OMB control number 0910–0338),
and 3397 (OMB control number 0910–
0297).
Respondents to this information
collection are sponsors and applicants
who seek fast track designation under
section 506 of the FD&C Act. The
Agency estimates the total annual
number of respondents submitting
requests for fast track designation to the
Center for Biologics Evaluation and
Research and the Center for Drug
Evaluation and Research is
approximately 81, and the number of
requests received is approximately 115
annually. FDA estimates that the
number of hours needed to prepare a
request for fast track designation is
approximately 60 hours per request.
Not all requests for fast track
designation may meet the statutory
standard. Of the requests for fast track
designation made per year, the Agency
granted approximately 100 requests
from 81 respondents, and for each of
these granted requests a premeeting
package was submitted to the Agency.
FDA estimates that the preparation
hours are approximately 100 hours per
premeeting package.
In the Federal Register of August 1,
2014 (79 FR 44780), 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—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance for industry: Fast track drug development
programs: Designation, development, and
application review
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Designation Requests ..........................................................
81
1.42
115
60
6,900
Premeeting Packages ..........................................................
81
1.09
88
100
8,800
Total ..............................................................................
........................
........................
........................
........................
15,700
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29607 Filed 12–17–14; 8:45 am]
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]]>Agencies
[Federal Register Volume 79, Number 243 (Thursday, December 18, 2014)]
[Notices]
[Pages 75564-75565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29607]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0996]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Fast Track Drug Development Programs: Designation,
Development, and Application Review
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 January
20, 2015.
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 0910-0389.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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.
Guidance for Industry: Fast Track Drug Development Programs:
Designation, Development, and Application Review--(OMB Control Number
0910-0389)--Extension
Section 112(a) of the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Pub. L. 105-115) amended the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) by adding section 506 (21 U.S.C. 356).
The section authorizes FDA to take appropriate action to facilitate the
development and expedite the review of new drugs, including biological
products, intended to treat a serious or life-threatening condition and
that demonstrate a potential to address an unmet medical need. Under
section 112(b) of FDAMA, FDA issued guidance to industry on fast track
policies and procedures outlined in section 506 of the FD&C Act. The
guidance discusses collections of information that are specified under
section 506 of the FD&C Act, other sections of the Public Health
Service Act (the PHS Act), or implementing regulations. The guidance
describes three general areas involving the collection of information:
(1) Fast track designation requests, (2) premeeting packages, and (3)
requests to submit portions of an application. Of these, fast track
designation requests and premeeting packages, in support of receiving a
fast track program benefit, provide for additional collections of
information not covered elsewhere in statute or regulation. Information
in support of fast track designation or fast track program benefits
that has previously been submitted to the Agency, may, in some cases,
be incorporated into the request by referring to the information rather
than resubmitting it.
Under section 506(a)(1) of the FD&C Act, an applicant who seeks
fast track designation is required to submit a request to the Agency
showing that the drug product: (1) Is intended for a serious or life-
threatening condition and (2) has the potential to address an
[[Page 75565]]
unmet medical need. The Agency expects that information to support a
designation request will have been gathered under existing provisions
of the FD&C Act, the PHS Act, or the implementing regulations. If such
information has already been submitted to the Agency, the information
may be summarized in the fast track designation request. The guidance
recommends that a designation request include, where applicable,
additional information not specified elsewhere by statute or
regulation. For example, additional information may be needed to show
that a product has the potential to address an unmet medical need where
an approved therapy exists for the serious or life-threatening
condition to be treated. Such information may include clinical data,
published reports, summaries of data and reports, and a list of
references. The amount of information and discussion in a designation
request need not be voluminous, but it should be sufficient to permit a
reviewer to assess whether the criteria for fast track designation have
been met.
After the Agency makes a fast track designation, a sponsor or
applicant may submit a premeeting package that may include additional
information supporting a request to participate in certain fast track
programs. The premeeting package serves as background information for
the meeting and should support the intended objectives of the meeting.
As with the request for fast track designation, the Agency expects that
most sponsors or applicants will have gathered such information to meet
existing requirements under the FD&C Act, the PHS Act, or implementing
regulations. These may include descriptions of clinical safety and
efficacy trials not conducted under an investigational new drug
application (i.e., foreign studies) and information to support a
request for accelerated approval. If such information has already been
submitted to FDA, the information may be summarized in the premeeting
package. Consequently, FDA anticipates that the additional collection
of information attributed solely to the guidance will be minimal.
Under section 506(c) of the FD&C Act, a sponsor must submit
sufficient clinical data for the Agency to determine, after preliminary
evaluation, that a fast track product may be effective. Section 506(c)
also requires that an applicant provide a schedule for the submission
of information necessary to make the application complete before FDA
can commence its review. The guidance does not provide for any new
collection of information regarding the submission of portions of an
application that are not required under section 506(c) of the FD&C Act
or any other provision of the FD&C Act.
All forms referred to in the guidance have current OMB approval:
Forms FDA 1571 (OMB control number 0910-0014), 356h (OMB control number
0910-0338), and 3397 (OMB control number 0910-0297).
Respondents to this information collection are sponsors and
applicants who seek fast track designation under section 506 of the
FD&C Act. The Agency estimates the total annual number of respondents
submitting requests for fast track designation to the Center for
Biologics Evaluation and Research and the Center for Drug Evaluation
and Research is approximately 81, and the number of requests received
is approximately 115 annually. FDA estimates that the number of hours
needed to prepare a request for fast track designation is approximately
60 hours per request.
Not all requests for fast track designation may meet the statutory
standard. Of the requests for fast track designation made per year, the
Agency granted approximately 100 requests from 81 respondents, and for
each of these granted requests a premeeting package was submitted to
the Agency. FDA estimates that the preparation hours are approximately
100 hours per premeeting package.
In the Federal Register of August 1, 2014 (79 FR 44780), 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--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Guidance for industry: Fast
track drug development Number of Average
programs: Designation, Number of responses per Total annual burden per Total hours
development, and application respondents respondent responses response
review
----------------------------------------------------------------------------------------------------------------
Designation Requests............ 81 1.42 115 60 6,900
Premeeting Packages............. 81 1.09 88 100 8,800
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 15,700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29607 Filed 12-17-14; 8:45 am]
BILLING CODE 4164-01-P
