Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions, 2867-2868 [2010-783]
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Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
submitted for an application with the
actual submitted application by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Devices and Radiological
Health (CDRH) and the Center for
Biologics Evaluation and Research
(CBER) to initiate the administrative
screening of new medical device
applications and supplemental
applications. The total number of
annual responses is based on the
number of cover sheet submissions
received by FDA in fiscal year (FY)
2008. CDRH received approximately
5,095 annual responses that included
the following submissions: 16 premarket
approval applications (PMAs) (PDP,
PMR, and BLA),1 3,625 premarket
notifications, 8 modular premarket
applications, 9 panel track supplements,
201 real-time supplements, 173 180-day
supplements, 633 30-day notices, 93
513(g) requests, and 337 annual fees for
periodic reporting.
CBER received approximately 97
annual responses that included the
following submissions: 2 PMAs, 1 BLA
efficacy supplement, 50 premarket
notifications, 3 180-day supplements, 2
2867
real-time supplements, 20 30-day
notices, 3 513(g) requests, and 16 annual
fees for periodic reporting. The number
of received annual responses in FY 2008
included the cover sheets for
applications that were qualified for
small businesses and fee waivers or
reductions. The estimated hours per
response are based on past FDA
experience with the various cover sheet
submissions, and range from 5 to 30
minutes. The hours per response are
based on the average of these estimates.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
FDA Form No.
No. of Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Medical Device Manufacturers ................
3601
5,192
1
5,192
18/60
1,558
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In the Federal Register of October 15,
2009 (74 FR 52965), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–790 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0465]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Additive
Petitions
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
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 February
18, 2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0546. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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.
Food Additive Petitions (OMB Control
Number 0910–0546)—Extension
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe
unless its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of the act specifies the
information that must be submitted by
a petition in order to establish the safety
of a food additive and to secure the
issuance of a regulation permitting its
use.
To implement the provision of section
409 of the act, procedural regulations
have been issued under part 571 (21
CFR part 571). These procedural
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broader terms by the law. The
regulations add no substantive
requirements to those indicated in the
law, but seek to explain the
requirements and provide a standard
format for submission of petitions, that
when implemented, will speed up the
time for processing. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in 21 CFR parts 573, 582, and
584 of the act. The labeling regulations
are considered by FDA to be cross
referenced to § 571.1, which is the
subject of this same OMB clearance for
food additive petitions.
In the Federal Register of October 6,
2009 (74 FR 51287), 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:
1 PDP means product development protocol, PMR
means postmarketing requirements, and BLA means
biologics license applications.
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19JAN1
2868
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency of
Response
Total Annual
Responses
Hours
per Response
Total Hours
571.1(c) moderate category
1
1
1
3,000
3,000
571.1(c) complex category
1
1
1
10,000
10,000
571.6 amendment of petition
2
2
4
1300
5,200
Total Hours
1There
18,200
are no capital costs or operating and maintenance costs associated with this collection of information.
571.1(c) moderate category: For food
additive petition without complex
chemistry, manufacturing, efficacy or
safety issues, the estimated time
requirement per petition is
approximately 3,000 hours. An average
of one petitions of this type is received
on an annual basis, resulting in a
burden of 3,000 hours.
571.1(c) complex category: For a food
additive petition with complex
chemistry, manufacturing, efficacy and/
or safety issues, the estimated time
requirement per petition is
approximately 10,000 hours. An average
of one petition of this type is received
on an annual basis, resulting in a
burden of 10,000 hours.
571.6: For a food additive petition
amendment, the estimated time
requirement per petition is
approximately 1,300 hours. An average
of four petitions of this type is received
on an annual basis, resulting in a
burden of 5,200 hours.
Thus, the estimated total annual
burden for this information collection is
18,200 hours.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–783 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on DSKJ8SOYB1PROD with NOTICES
[Docket No. FDA–2009–N–0487]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Informed Consent For In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
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 February
18, 2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0582. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@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 on Informed Consent For In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable—(OMB
Control Number 0910–0582)—Extension
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and with ethical
standards. Investigators should have
freedom to pursue the least burdensome
means of accomplishing this goal.
However, to ensure that the balance is
maintained between product
development and the protection of
public health, safety, and ethical
standards, FDA has established human
subject protection regulations
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addressing requirements for informed
consent and institutional review board
(IRB) review that apply to all FDAregulated clinical investigations
involving human subjects. In particular,
informed consent requirements further
both safety and ethical considerations
by allowing potential subjects to
consider both the physical and privacy
risks they face if they agree to
participate in a trial.
Under FDA regulations, clinical
investigations using human specimens
conducted in support of premarket
submissions to FDA are considered
human subject investigations (see 21
CFR 812.3(p)). Many investigational
device studies are exempt from most
provisions of part 812 (21 CFR part 812),
Investigational Device Exemptions,
under § 812.2(c)(3), but FDA’s
regulations for the protection of human
subjects (21 CFR parts 50 and 56) apply
to all clinical investigations that are
regulated by FDA (see 21 CFR 50.1; 21
CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and
21 U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain
exceptions from the requirements of
informed consent on the grounds that
the specimens are not identifiable or
that they are remnants of human
specimens collected for routine clinical
care or analysis that would otherwise
have been discarded. Nor do FDA
regulations allow IRBs to decide
whether or not to waive informed
consent for research involving leftover
or unidentifiable specimens.
In a level one guidance document
issued under the Good Guidances
Practices regulation, 21 CFR 10.115,
FDA outlines the circumstances in
which it intends to exercise
enforcement discretion as to the
informed consent regulations for
clinical investigators, sponsors, and
IRBs.
The recommendations of this
guidance impose a minimal burden on
industry. FDA estimates that 700 studies
will be affected annually. Each study
will result in one recordkeeping per
year, estimated to take 4 hours to
complete. This results in a total
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2867-2868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-783]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0465]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Additive
Petitions
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
February 18, 2010.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0546.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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.
Food Additive Petitions (OMB Control Number 0910-0546)--Extension
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe unless its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of the act specifies the information that must be submitted by a
petition in order to establish the safety of a food additive and to
secure the issuance of a regulation permitting its use.
To implement the provision of section 409 of the act, procedural
regulations have been issued under part 571 (21 CFR part 571). These
procedural regulations are designed to specify more thoroughly the
information that must be submitted to meet the requirement set down in
broader terms by the law. The regulations add no substantive
requirements to those indicated in the law, but seek to explain the
requirements and provide a standard format for submission of petitions,
that when implemented, will speed up the time for processing. Labeling
requirements for food additives intended for animal consumption are
also set forth in various regulations contained in 21 CFR parts 573,
582, and 584 of the act. The labeling regulations are considered by FDA
to be cross referenced to Sec. 571.1, which is the subject of this
same OMB clearance for food additive petitions.
In the Federal Register of October 6, 2009 (74 FR 51287), 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:
[[Page 2868]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(c) moderate category 1 1 1 3,000 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(c) complex category 1 1 1 10,000 10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.6 amendment of petition 2 2 4 1300 5,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours 18,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
571.1(c) moderate category: For food additive petition without
complex chemistry, manufacturing, efficacy or safety issues, the
estimated time requirement per petition is approximately 3,000 hours.
An average of one petitions of this type is received on an annual
basis, resulting in a burden of 3,000 hours.
571.1(c) complex category: For a food additive petition with
complex chemistry, manufacturing, efficacy and/or safety issues, the
estimated time requirement per petition is approximately 10,000 hours.
An average of one petition of this type is received on an annual basis,
resulting in a burden of 10,000 hours.
571.6: For a food additive petition amendment, the estimated time
requirement per petition is approximately 1,300 hours. An average of
four petitions of this type is received on an annual basis, resulting
in a burden of 5,200 hours.
Thus, the estimated total annual burden for this information
collection is 18,200 hours.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-783 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S
