Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Experience Reporting for Licensed Biological Products; and General Records, 49296 [05-16659]
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49296
Federal Register / Vol. 70, No. 162 / Tuesday, August 23, 2005 / Notices
meets the requirements of the
regulations promulgated by the
Secretary to authorize the use of such a
health claim. Section 101.82 (21 CFR
101.82) of FDA’s regulations authorizes
a health claim for food labels about soy
protein and the risk of coronary heart
disease. To bear the soy protein/
coronary heart disease health claim,
foods must contain at least 6.25 grams
of soy protein per reference amount
customarily consumed. Analytical
methods for measuring total protein can
be used to quantify the amount of soy
protein in foods that contain soy as the
sole source of protein. However, at the
present time there is no validated
analytical methodology available to
quantify the amount of soy protein in
foods that contain other sources of
protein. For these latter foods, FDA
must rely on information known only to
the manufacturer to assess compliance
with the requirement that the food
contain the qualifying amount of soy
protein. Thus, FDA requires
manufacturers to have and keep records
to substantiate the amount of soy
protein in a food that bears the health
claim and contains sources of protein
other than soy, and to make such
records available to appropriate
regulatory officials upon written
request. The information collected
includes nutrient data bases or analyses,
recipes or formulations, purchase orders
for ingredients, or any other information
that reasonably substantiates the ratio of
soy protein to total protein.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of Recordkeepers
101.82(c)(2)(ii)(B)
1There
Annual Frequency per
Recordkeeping
25
1
Hours per
Record
25
Total Hours
1
25
are no capital costs or operating and maintenance costs associated with this collection of information.
Based upon its experience with the
use of health claims, FDA estimates that
only about 25 firms would be likely to
market products bearing a soy protein/
coronary heart disease health claim and
that only, perhaps, one of each firm’s
products might contain nonsoy sources
of protein along with soy protein. The
records required to be retained by
§ 101.82(c)(2)(ii)(B) are the records, e.g.,
the formulation or recipe, that a
manufacturer has and maintains as a
normal course of its doing business.
Thus, the burden to the food
manufacturer is that involved in
assembling and providing the records to
appropriate regulatory officials for
review or copying.
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16658 Filed 8–22–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0469]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Adverse Experience Reporting for
Licensed Biological Products; and
General Records
AGENCY:
‘‘Adverse Experience Reporting for
Licensed Biological Products; and
General Records’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
In the
Federal Register of April 20, 2005 (70
FR 20571), 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 0910–0308. 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:
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–16659 Filed 8–22–05; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
ACTION:
Total Annual
Records
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0310]
Draft Guidance for Industry on Gene
Therapy Clinical Trials—Observing
Participants for Delayed Adverse
Events; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Gene Therapy
Clinical Trials—Observing Participants
for Delayed Adverse Events,’’ dated
August 2005. The draft guidance
provides sponsors of gene therapy
studies with recommendations
regarding collection of data on delayed
adverse events in participants who have
been exposed to gene therapy products.
When finalized, this guidance will
supplement the recommendations in the
‘‘Guidance for Industry: Supplemental
Guidance on Testing for Replication
Competent Retrovirus in Retroviral
Vector Based Gene Therapy Products
and During Follow-up of Patients in
Clinical Trials Using Retroviral Vectors’’
(Retroviral Vector guidance), dated
October 2000, for study participant
long-term followup. However, the
recommendations in the Retroviral
Vector guidance regarding the length of
followup will be superseded by this
Gene Therapy Clinical Trials guidance.
DATES: Submit written or electronic
comments on the draft guidance by
November 21, 2005, to ensure their
E:\FR\FM\23AUN1.SGM
23AUN1
]]>Agencies
[Federal Register Volume 70, Number 162 (Tuesday, August 23, 2005)]
[Notices]
[Page 49296]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16659]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0469]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Adverse Experience Reporting for
Licensed Biological Products; and General Records
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Adverse Experience Reporting for
Licensed Biological Products; and General Records'' has been approved
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 20, 2005
(70 FR 20571), 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 0910-0308.
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.
Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16659 Filed 8-22-05; 8:45 am]
BILLING CODE 4160-01-S
