Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 49294-49295 [05-16656]
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49294
Federal Register / Vol. 70, No. 162 / Tuesday, August 23, 2005 / Notices
collection. E-mail address:
grjohnson@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer for
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: August 16, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–16641 Filed 8–19–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0153]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
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 September
22, 2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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.
Regulations For In Vivo
Radiopharmaceuticals Used For
Diagnosis and Monitoring—(OMB
Control Number 0910–0409)—Extension
In response to the requirements of
section 122 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Public Law 105–115),
FDA published a final rule (64 FR
26675, May 17, 1999) amending its
regulations by adding provisions that
clarify FDA’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 (the act) (21 U.S.C.
355) and section 351 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 262). 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 act and the PHS Act.
The information, which is usually
submitted as part of a new drug
application (NDA), 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 21 CFR part 315, information
required under the 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 (OMB control number 0910–
0001, approved by OMB until March 31,
2005). 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.
The burden totals do not include an
increase in burden. This estimate does
not include the actual time needed to
conduct studies and trials or other
research from which the reported
information is obtained.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
315.4, 315.5, and 315.6
VerDate Aug<18>2005
15:03 Aug 22, 2005
Annual Frequency
per Response
2
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1
Fmt 4703
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Total Annual
Responses
Hours per
Response
2
E:\FR\FM\23AUN1.SGM
2,000
23AUN1
Total Hours
4,000
Federal Register / Vol. 70, No. 162 / Tuesday, August 23, 2005 / Notices
49295
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
4,000
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
In the Federal Register of May 3, 2005
(70 FR 22887), FDA published a 60-day
notice requesting public comment on
the information collection provisions.
No comments were received.
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16656 Filed 8–22–05; 8:45 am]
BILLING CODE 4160–01–S
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16657 Filed 8–22–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0317]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
Claim
Food and Drug Administration
[Docket No. 2005N–0029]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Infant Formula Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Total Hours
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Infant Formula Recall Regulations’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In the
Federal Register of February 1, 2005 (70
FR 5188), 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 0910–0188. The
approval expires on July 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
VerDate Aug<18>2005
15:03 Aug 22, 2005
Jkt 205001
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 record retention requirement of the
soy protein/coronary heart disease
health claim.
DATES: Submit written or electronic
comments on the collection of
information by October 24, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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.
Record Retention Requirements for the
Soy Protein and Risk of Coronary Heart
Disease Health Claim—21 CFR
101.82(c)(2)(ii)(B) (OMB Control
Number 0910–0428)—Extension
Section 403(r)(3)(A)(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
343(r)(3)(A)(i)) provides for the use of
food label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health related
condition only where that statement
E:\FR\FM\23AUN1.SGM
23AUN1
]]>Agencies
[Federal Register Volume 70, Number 162 (Tuesday, August 23, 2005)]
[Notices]
[Pages 49294-49295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16656]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0153]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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
September 22, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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.
Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis and
Monitoring--(OMB Control Number 0910-0409)--Extension
In response to the requirements of section 122 of the Food and Drug
Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115),
FDA published a final rule (64 FR 26675, May 17, 1999) amending its
regulations by adding provisions that clarify FDA'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 (the act) (21 U.S.C. 355) and section 351 of the
Public Health Service Act (the PHS Act) (42 U.S.C. 262). 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 act and the PHS Act. The information, which is
usually submitted as part of a new drug application (NDA), 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 21 CFR part 315, information
required under the 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 (OMB control number 0910-0001, approved by OMB until March 31,
2005). 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. The burden totals do not
include an increase in burden. This estimate does not include the
actual time needed to conduct studies and trials or other research from
which the reported information is obtained.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
315.4, 315.5, and 2 1 2 2,000 4,000
315.6
----------------------------------------------------------------------------------------------------------------
[[Page 49295]]
Total 4,000
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
In the Federal Register of May 3, 2005 (70 FR 22887), FDA published
a 60-day notice requesting public comment on the information collection
provisions. No comments were received.
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16656 Filed 8-22-05; 8:45 am]
BILLING CODE 4160-01-S
