Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators, 43843-43844 [2012-18235]
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43843
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
irradiation process (e.g., the food
treated, lot identification, scheduled
process, etc.). The records required by
§ 179.25(e) are used by FDA inspectors
to assess compliance with the regulation
that establishes limits within which
radiation may be safely used to treat
food. The Agency cannot ensure safe
use without a method to assess
compliance with the dose limits, and
there are no practicable methods for
comment on the proposed collection of
information. One comment was received
outside the scope of the four collection
of information topics solicited by the
notice.
Description of respondents:
Respondents are businesses engaged in
the irradiation of food.
FDA estimates the burden of this
collection of information as follows:
analyzing most foods to determine
whether they have been treated with
ionizing radiation and are within the
limitations set forth in part 179. Records
inspection is the only way to determine
whether firms are complying with the
regulations for treatment of foods with
ionizing radiation.
In the Federal Register of May 17,
2012 (77 FR 29352), FDA published a
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
179.25(e), Large Processors ...............................................
179.25(e), Small Processors ...............................................
3
4
300
30
900
120
1
1
900
120
Total ..............................................................................
........................
........................
........................
........................
1,020
TKELLEY on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of burden for
the recordkeeping provisions of
§ 179.25(e) on the Agency’s experience
regulating the safe use of radiation as a
direct food additive. The number of
firms who process food using irradiation
is extremely limited. FDA estimates that
there are 3 irradiation plants whose
business is devoted primarily (i.e.,
approximately 100 percent) to
irradiation of food and other agricultural
products. Four other firms also irradiate
small quantities of food. FDA estimates
that this irradiation accounts for no
more than 10 percent of the business for
each of these firms. Therefore, the
average estimated burden is based on 3
facilities devoting 100 percent of their
business to food irradiation (3 × 300
hours = 900 hours for recordkeeping
annually), and 4 facilities devoting 10
percent of their business to food
irradiation (4 × 30 hours = 120 hours for
recordkeeping annually).
No burden has been estimated for the
labeling requirements in §§ 179.21(b)(1),
179.21(b)(2), and 179.26(c) because the
information to be disclosed is
information that has been supplied by
FDA. Under 5 CFR 1320.3(c)(2), the
public disclosure of information
originally supplied by the Federal
Government to the recipient for the
purpose of disclosure to the public is
not a collection of information.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0280]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Financial
Disclosure by Clinical Investigators
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: July 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
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 August 27,
2012.
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 0910–0396. Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2012–18234 Filed 7–25–12; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
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SUMMARY:
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400B, Rockville, MD 20850, 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.
Financial Disclosure by Clinical
Investigators—(OMB Control Number
0910–0396)—Extension
Respondents to this collection are
sponsors of marketing applications that
contain clinical data from studies
covered by the regulations. These
sponsors represent pharmaceutical,
biologic, and medical device firms.
Respondents are also clinical
investigators who provide financial
information to the sponsors of
marketing applications.
Under § 54.4(a) (21 CFR 54.4(a)),
applicants submitting an application
that relies on clinical studies must
submit a complete list of clinical
investigators who participated in a
covered clinical study, and must either
certify to the absence of certain financial
arrangements with clinical investigators
(Form FDA 3454) or, under § 54.4(a)(3),
disclose to FDA the nature of those
arrangements and the steps taken by the
applicant or sponsor to minimize the
potential for bias (Form FDA 3455).
Under § 54.6, the sponsors of covered
studies must maintain complete records
of compensation agreements with any
compensation paid to nonemployee
clinical investigators, including
information showing any financial
interests held by the clinical
investigator, for a time period of 2 years
after the date of approval of the
applications. Sponsors of covered
studies maintain many records with
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43844
Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices
regard to clinical investigators,
including protocol agreements and
investigator resumes or curriculum
vitae. FDA estimates than an average of
15 minutes will be required for each
recordkeeper to add this record to the
clinical investigators’ file.
Under § 54.4(b), clinical investigators
supply to the sponsor of a covered study
financial information sufficient to allow
the sponsor to submit complete and
accurate certification or disclosure
statements. Clinical investigators are
accustomed to supplying such
information when applying for research
grants. Also, most people know the
financial holdings of their immediate
family and records of such interests are
generally accessible because they are
needed for preparing tax records. For
these reasons, FDA estimates that it will
take clinical investigators 15 minutes to
submit such records to the sponsor.
Subsequent to publication of the
60-day notice, FDA reestimated the
information collection. Upon additional
inspection of the data, FDA has updated
the estimated recordkeeping burden
hours to more accurately reflect the
burden.
In the Federal Register of March 28,
2012 (77 FR 18826), 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
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Certification—54.4(a)(1) and (a)(2)—Form FDA 3454 ........
Disclosure—54.4(a)(3)—Form FDA 3455 ...........................
Total ..............................................................................
902
90
........................
1
1
........................
902
90
........................
1
5
........................
1 There
Total hours
902
450
1,352
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping—54.6 ..........................................................
902
1
902
0.25
226
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
21 CFR Section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Clinical Investigators—54.4(b) .............................................
10,554
1
10,554
0.17
1,794
Dated: July 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments
concerning collection of information
using Form FDA 3794 entitled ‘‘Generic
Drug User Fee Cover Sheet.’’
[FR Doc. 2012–18235 Filed 7–25–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Drug User
Fee Cover Sheet; Form FDA 3794
TKELLEY on DSK3SPTVN1PROD with NOTICES
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
SUMMARY:
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Submit either electronic or
written comments on the collection of
information by September 24, 2012.
DATES:
[Docket No. FDA–2012–N–0748]
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.
ADDRESSES:
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FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–7651,
juanmanuel.vilela@fda.hhs.gov.
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 before submitting the
collection to OMB for approval. To
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43843-43844]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18235]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0280]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Financial Disclosure
by Clinical Investigators
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 August
27, 2012.
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 0910-0396.
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, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 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.
Financial Disclosure by Clinical Investigators--(OMB Control Number
0910-0396)--Extension
Respondents to this collection are sponsors of marketing
applications that contain clinical data from studies covered by the
regulations. These sponsors represent pharmaceutical, biologic, and
medical device firms. Respondents are also clinical investigators who
provide financial information to the sponsors of marketing
applications.
Under Sec. 54.4(a) (21 CFR 54.4(a)), applicants submitting an
application that relies on clinical studies must submit a complete list
of clinical investigators who participated in a covered clinical study,
and must either certify to the absence of certain financial
arrangements with clinical investigators (Form FDA 3454) or, under
Sec. 54.4(a)(3), disclose to FDA the nature of those arrangements and
the steps taken by the applicant or sponsor to minimize the potential
for bias (Form FDA 3455).
Under Sec. 54.6, the sponsors of covered studies must maintain
complete records of compensation agreements with any compensation paid
to nonemployee clinical investigators, including information showing
any financial interests held by the clinical investigator, for a time
period of 2 years after the date of approval of the applications.
Sponsors of covered studies maintain many records with
[[Page 43844]]
regard to clinical investigators, including protocol agreements and
investigator resumes or curriculum vitae. FDA estimates than an average
of 15 minutes will be required for each recordkeeper to add this record
to the clinical investigators' file.
Under Sec. 54.4(b), clinical investigators supply to the sponsor
of a covered study financial information sufficient to allow the
sponsor to submit complete and accurate certification or disclosure
statements. Clinical investigators are accustomed to supplying such
information when applying for research grants. Also, most people know
the financial holdings of their immediate family and records of such
interests are generally accessible because they are needed for
preparing tax records. For these reasons, FDA estimates that it will
take clinical investigators 15 minutes to submit such records to the
sponsor.
Subsequent to publication of the 60-day notice, FDA reestimated the
information collection. Upon additional inspection of the data, FDA has
updated the estimated recordkeeping burden hours to more accurately
reflect the burden.
In the Federal Register of March 28, 2012 (77 FR 18826), 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\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Certification--54.4(a)(1) and 902 1 902 1 902
(a)(2)--Form FDA 3454..........
Disclosure--54.4(a)(3)--Form FDA 90 1 90 5 450
3455...........................
Total....................... .............. .............. .............. .............. 1,352
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping--54.6................................................ 902 1 902 0.25 226
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 3--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Investigators--54.4(b).................................... 10,554 1 10,554 0.17 1,794
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: July 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18235 Filed 7-25-12; 8:45 am]
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