Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 42337-42338 [2014-17079]
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Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices
42337
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
Number of pretest/study completes ..................................
6,300
........................
........................
...........................
........................
Total ...........................................................................
........................
........................
........................
...........................
8,065
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
emcdonald on DSK67QTVN1PROD with NOTICES
1. Southwell, B.G., ‘‘On the Need for a LifeSpan Approach to Health Campaign
Evaluation.’’ Health Communication, 25
(6–7), 525–528, 2010.
2. Lerner, R.M. and L. Steinberg, ‘‘The
Scientific Study of Adolescent
Development.’’ In R.M. Lerner and L.
Steinberg (Eds.), Handbook of
Adolescent Psychology (3rd ed., Vol. 1:
Individual Bases of Adolescent
Development). Hoboken, NJ: John Wiley
and Sons, 2009.
3. Erikson, E.H., The Child and Society. New
York: Norton, 1963.
4. Erikson, E.H., Dimensions of a New
Identity. New York: Norton, 1974.
5. Piaget, J., The Origins of Intelligence in
Children. New York: Internal University
Press, 1952.
6. Piaget, J., The Child’s Conception of the
World. Totowa, NJ: Littlefield, Adams,
1972.
7. Kohlberg, L., ‘‘Stage and Sequence. The
Cognitive Developmental Approach to
Socialization.’’ In D.A. Goslin (Ed.),
Handbook of Socialization Theory of
Research (pp. 347–380). Chicago: Rand
McNally, 1969.
8. Rubia, K., S. Overmeyer, E. Taylor, et al.,
‘‘Functional Frontalisation with Age:
Mapping Neurodevelopmental
Trajectories with fMRI.’’ [Clinical Trial
Research Support, Non-U.S. Gov’t.].
Neuroscience and Biobehavioral
Reviews, 24(1), 13–19, 2000.
9. Goldberg, J.H., B.L. Halpern-Felsher, and
S.G. Millstein, ‘‘Beyond Invulnerability:
The Importance of Benefits in
Adolescents’ Decision to Drink Alcohol.’’
Health Psychology, 21(5), 477–484. doi:
10.1037/0278–6133.21.5.477, 2002.
10. Albert, D. and L. Steinberg, ‘‘Judgment
and Decision Making in Adolescence.’’
Journal of Research on Adolescence,
21(1), 211–224. doi: 10.1111/j.1532–
7795.2010.00724.x, 2011.
Dated: July 15, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–16998 Filed 7–18–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Mar<15>2010
17:14 Jul 18, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0998]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection in the
regulations for in vivo
radiopharmaceuticals used for diagnosis
and monitoring.
DATES: Submit either electronic or
written comments on the collection of
information by September 19, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring—21 CFR Part
315—(OMB Control Number 0910–
0409)—Extension
FDA is requesting OMB approval of
the information collection requirements
contained in 21 CFR 315.4, 315.5, and
315.6. These regulations require
manufacturers of diagnostic
radiopharmaceuticals to submit
information that demonstrates the safety
and effectiveness of a new diagnostic
radiopharmaceutical or of a new
E:\FR\FM\21JYN1.SGM
21JYN1
42338
Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices
indication for use of an approved
diagnostic radiopharmaceutical.
In response to the requirements of
section 122 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115), FDA published
a final rule in the Federal Register of
May 17, 1999 (64 FR 26657), amending
its regulations by adding provisions that
clarify the Agency’s evaluation and
approval of in vivo
radiopharmaceuticals used in the
diagnosis or monitoring of diseases. The
regulation describes the kinds of
indications of diagnostic
radiopharmaceuticals and some of the
criteria that the Agency would use to
evaluate the safety and effectiveness of
a diagnostic radiopharmaceutical under
section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) (the
FD&C Act) and section 351 of the Public
Health Service Act (42 U.S.C. 262) (the
PHS Act). Information about the safety
or effectiveness of a diagnostic
radiopharmaceutical enables FDA to
properly evaluate the safety and
effectiveness profiles of a new
diagnostic radiopharmaceutical or a
new indication for use of an approved
diagnostic radiopharmaceutical.
The rule clarifies existing FDA
requirements for approval and
evaluation of drug and biological
products already in place under the
authorities of the FD&C Act and the PHS
Act. The information, which is usually
submitted as part of a new drug
application or biologics license
application or as a supplement to an
approved application, typically
includes, but is not limited to,
nonclinical and clinical data on the
pharmacology, toxicology, adverse
events, radiation safety assessments,
and chemistry, manufacturing, and
controls. The content and format of an
application for approval of a new drug
are set forth in § 314.50 (21 CFR 314.50).
Under part 315, information required
under the FD&C Act and needed by FDA
to evaluate the safety and effectiveness
of in vivo radiopharmaceuticals still
needs to be reported.
Based on the number of submissions
(that is, human drug applications and/
or new indication supplements for
diagnostic radiopharmaceuticals) that
FDA receives, the Agency estimates that
it will receive approximately two
submissions annually from two
applicants. The hours per response
refers to the estimated number of hours
that an applicant would spend
preparing the information required by
the regulations. Based on FDA’s
experience, the Agency estimates the
time needed to prepare a complete
application for a diagnostic
radiopharmaceutical to be
approximately 10,000 hours, roughly
one-fifth of which, or 2,000 hours, is
estimated to be spent preparing the
portions of the application that would
be affected by these regulations. The
regulation does not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours
because safety and effectiveness
information is already required by
§ 314.50 (collection of information
approved under OMB control number
0910–0001). In fact, clarification in
these regulations of FDA’s standards for
evaluation of diagnostic
radiopharmaceuticals is intended to
streamline overall information
collection burdens, particularly for
diagnostic radiopharmaceuticals that
may have well-established, low-risk
safety profiles, by enabling
manufacturers to tailor information
submissions and avoid unnecessary
clinical studies. Table 1 of this
document contains estimates of the
annual reporting burden for the
preparation of the safety and
effectiveness sections of an application
that are imposed by existing regulations.
This estimate does not include the
actual time needed to conduct studies
and trials or other research from which
the reported information is obtained.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
315.4, 315.5, and 315.6 .......................................................
2
1
2
2,000
4,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
ACTION:
[FR Doc. 2014–17079 Filed 7–18–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with NOTICES
[Docket No. FDA–2014–N–0001]
Joint Meeting of the Bone,
Reproductive and Urologic Drugs
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
17:14 Jul 18, 2014
Jkt 232001
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Bone,
Reproductive and Urologic Drugs
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 18, 2014, from 8 a.m.
to 1 p.m.
Location: College Park Marriott Hotel
and Conference Center, 3501 University
Blvd. East, Hyattsville, MD 20783. The
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
hotel’s telephone number is 301–985–
7300.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, email: BRUDAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
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]]>Agencies
[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Pages 42337-42338]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0998]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection in
the regulations for in vivo radiopharmaceuticals used for diagnosis and
monitoring.
DATES: Submit either electronic or written comments on the collection
of information by September 19, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and
Monitoring--21 CFR Part 315--(OMB Control Number 0910-0409)--Extension
FDA is requesting OMB approval of the information collection
requirements contained in 21 CFR 315.4, 315.5, and 315.6. These
regulations require manufacturers of diagnostic radiopharmaceuticals to
submit information that demonstrates the safety and effectiveness of a
new diagnostic radiopharmaceutical or of a new
[[Page 42338]]
indication for use of an approved diagnostic radiopharmaceutical.
In response to the requirements of section 122 of the Food and Drug
Administration Modernization Act of 1997 (Pub. L. 105-115), FDA
published a final rule in the Federal Register of May 17, 1999 (64 FR
26657), amending its regulations by adding provisions that clarify the
Agency's evaluation and approval of in vivo radiopharmaceuticals used
in the diagnosis or monitoring of diseases. The regulation describes
the kinds of indications of diagnostic radiopharmaceuticals and some of
the criteria that the Agency would use to evaluate the safety and
effectiveness of a diagnostic radiopharmaceutical under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) (the FD&C Act)
and section 351 of the Public Health Service Act (42 U.S.C. 262) (the
PHS Act). Information about the safety or effectiveness of a diagnostic
radiopharmaceutical enables FDA to properly evaluate the safety and
effectiveness profiles of a new diagnostic radiopharmaceutical or a new
indication for use of an approved diagnostic radiopharmaceutical.
The rule clarifies existing FDA requirements for approval and
evaluation of drug and biological products already in place under the
authorities of the FD&C Act and the PHS Act. The information, which is
usually submitted as part of a new drug application or biologics
license application or as a supplement to an approved application,
typically includes, but is not limited to, nonclinical and clinical
data on the pharmacology, toxicology, adverse events, radiation safety
assessments, and chemistry, manufacturing, and controls. The content
and format of an application for approval of a new drug are set forth
in Sec. 314.50 (21 CFR 314.50). Under part 315, information required
under the FD&C Act and needed by FDA to evaluate the safety and
effectiveness of in vivo radiopharmaceuticals still needs to be
reported.
Based on the number of submissions (that is, human drug
applications and/or new indication supplements for diagnostic
radiopharmaceuticals) that FDA receives, the Agency estimates that it
will receive approximately two submissions annually from two
applicants. The hours per response refers to the estimated number of
hours that an applicant would spend preparing the information required
by the regulations. Based on FDA's experience, the Agency estimates the
time needed to prepare a complete application for a diagnostic
radiopharmaceutical to be approximately 10,000 hours, roughly one-fifth
of which, or 2,000 hours, is estimated to be spent preparing the
portions of the application that would be affected by these
regulations. The regulation does not impose any additional reporting
burden for safety and effectiveness information on diagnostic
radiopharmaceuticals beyond the estimated burden of 2,000 hours because
safety and effectiveness information is already required by Sec.
314.50 (collection of information approved under OMB control number
0910-0001). In fact, clarification in these regulations of FDA's
standards for evaluation of diagnostic radiopharmaceuticals is intended
to streamline overall information collection burdens, particularly for
diagnostic radiopharmaceuticals that may have well-established, low-
risk safety profiles, by enabling manufacturers to tailor information
submissions and avoid unnecessary clinical studies. Table 1 of this
document contains estimates of the annual reporting burden for the
preparation of the safety and effectiveness sections of an application
that are imposed by existing regulations. This estimate does not
include the actual time needed to conduct studies and trials or other
research from which the reported information is obtained.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
315.4, 315.5, and 315.6............................................ 2 1 2 2,000 4,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-17079 Filed 7-18-14; 8:45 am]
BILLING CODE 4164-01-P
