Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators, 79493-79495 [E8-30837]

Download as PDF Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: December 22, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–30832 Filed 12–24–08; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Performance Measures for Healthy Marriage and Promoting Responsible Fatherhood Grant Programs. OMB No.: New Collection. Description: The Office of Family Assistance (OFA), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), intends to request approval from the Office of Management and Budget (OMB) for the collection of performance measures from grantees for the Healthy Marriage and Promoting Responsible Fatherhood discretionary grant programs. The performance measure data obtained from the grantees will be used by OFA to report on the 79493 overall performance of this grant program and to inform the Program Assessment Rating Tool (PART) process if the program is selected for PART review. Data will be collected from all 118 Healthy Marriage and 96 Responsible Fatherhood grantees in the OFA program. Grantees will report on program outputs and outcomes in such areas as participant’s improvement in knowledge, skills, attitudes, and behaviors related to healthy marriage and responsible fatherhood. Grantees will be asked to input data for selected outputs and outcomes for activities funded under the grant. Grantees will extract data from program records and will report the data twice yearly through the ACF on-line data collection tool (OLDC). Training and assistance will be provided to grantees to support this data collection process. Respondents: Office of Family Assistance Funded Healthy Marriage and Promoting Responsible Fatherhood Grantees. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Performance measure reporting form .............................................................. dwashington3 on PROD1PC60 with NOTICES Instrument 214 2 0.80 342.40 Estimated Total Annual Burden Hours: 342.40. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@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, Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. VerDate Aug<31>2005 13:19 Dec 24, 2008 Jkt 217001 Dated: December 22, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–30833 Filed 12–24–08; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0637] Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information requiring the sponsor of any drug, biologic, or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing. DATES: Submit written or electronic comments on the collection of information by February 27, 2009. ADDRESSES: Submit electronic comments on the collection of information to http:// 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: Elizabeth Berbakos, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3792. E:\FR\FM\29DEN1.SGM 29DEN1 79494 Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices 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 SUPPLEMENTARY INFORMATION: 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. Financial Disclosure by Clinical Investigators (OMB Control Number 0910–0396)—Extension Respondents are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These sponsors represent pharmaceutical, biologic, and medical device firms. The applicant will incur reporting costs in order to comply with the final rule. Applicants will be required to submit, for example, the complete list of clinical investigators for each covered study, not employed by the applicant and/or sponsor of the covered study, and either certify to the absence of certain financial arrangements with clinical investigators or disclose the nature of those arrangements to FDA and the steps taken by the applicant or sponsor to minimize the potential for bias. The clinical investigator will have to supply information regarding financial interests or payments held in the sponsor of the covered study. FDA has said that it has no preference as to how this information is collected from investigators and that sponsors/applicants have the flexibility to collect the information in the most efficient and least burdensome manner that will be effective. FDA estimated that the total reporting costs of sponsors would be less than $450,000 annually. Costs could also occur after a marketing application is submitted if FDA determines that the financial interests of an investigator raise significant questions about the integrity of the data. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 54.4(a)(1) and (a)(2) Annual Frequency per Response Total Annual Responses Hours per Response 1,000 1 1,000 5 5,000 100 1 100 20 2,000 46,000 0.25 11,500 1 11,500 54.4(a)(3) 54.4 Total 1There Total Hours 18,500 are no capital costs or operating and maintenance costs associated with this collection of information. The sponsors of covered studies will be required to 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. This time is consistent with the current recordkeeping requirements for other information related to marketing applications for human drugs, biologics, and medical devices. Currently, sponsors of covered studies must maintain many records with 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 clinical investigators’ file. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Annual Frequency per Recordkeeping 1,000 21 CFR Section 1 54.6 Total Annual Records Hours per Record 1,000 dwashington3 on PROD1PC60 with NOTICES Total 1There 0.25 Total Hours 250 250 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Aug<31>2005 16:17 Dec 24, 2008 Jkt 217001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1 79495 Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. Dated: December 18, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–30837 Filed 12–24–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0652] Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation 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 reporting requirements for filing a notice of participation with FDA. DATES: Submit written or electronic comments on the collection of information by February 27, 2009. Submit electronic comments on the collection of information to http:// 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: Jonna Capezzuto, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794. 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 ADDRESSES: 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. Notice of Participation—21 CFR 12.45 (OMB Control Number 0910–0191)— Extension Section 12.45 (21 CFR 12.45) issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation, state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or, in the case of a hearing before a Public Board of Inquiry, concerning disclosure of data and information by participants (21 CFR 13.25). In accordance with § 12.45(e) the presiding officer may omit a participant’s appearance. The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the pre-hearing conference and commits participation. The respondents are individuals or households, State or local governments, not-for-profit institutions and businesses, or other for-profit groups and institutions. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 12.45 dwashington3 on PROD1PC60 with NOTICES 1 There Annual Frequency per Response 8 Total Annual Responses 1 Hours per Response 8 Total Hours 3 24 are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimates for this collection of information are based on agency records and experience over the past 3 years. Please note that on January 15, 2008, the FDA Division of Dockets VerDate Aug<31>2005 13:19 Dec 24, 2008 Jkt 217001 Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 accepted by FDA only through FDMS at http://www.regulations.gov. E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 73, Number 249 (Monday, December 29, 2008)]
[Notices]
[Pages 79493-79495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30837]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0637]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Financial Disclosure by Clinical Investigators

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 information requiring the 
sponsor of any drug, biologic, or device marketing application to 
certify to the absence of clinical investigators and/or disclose those 
financial interests as required, when covered clinical studies are 
submitted to FDA in support of product marketing.

DATES: Submit written or electronic comments on the collection of 
information by February 27, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

[[Page 79494]]


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.

Financial Disclosure by Clinical Investigators (OMB Control Number 
0910-0396)--Extension

    Respondents are sponsors of marketing applications that contain 
clinical data from studies covered by the regulations. These sponsors 
represent pharmaceutical, biologic, and medical device firms. The 
applicant will incur reporting costs in order to comply with the final 
rule. Applicants will be required to submit, for example, the complete 
list of clinical investigators for each covered study, not employed by 
the applicant and/or sponsor of the covered study, and either certify 
to the absence of certain financial arrangements with clinical 
investigators or disclose the nature of those arrangements to FDA and 
the steps taken by the applicant or sponsor to minimize the potential 
for bias. The clinical investigator will have to supply information 
regarding financial interests or payments held in the sponsor of the 
covered study. FDA has said that it has no preference as to how this 
information is collected from investigators and that sponsors/
applicants have the flexibility to collect the information in the most 
efficient and least burdensome manner that will be effective. FDA 
estimated that the total reporting costs of sponsors would be less than 
$450,000 annually. Costs could also occur after a marketing application 
is submitted if FDA determines that the financial interests of an 
investigator raise significant questions about the integrity of the 
data.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                          Annual Frequency per     Total Annual        Hours per
  21 CFR Section     No. of Respondents         Response             Responses          Response     Total Hours
----------------------------------------------------------------------------------------------------------------
54.4(a)(1) and                     1,000                     1               1,000                5        5,000
 (a)(2)
----------------------------------------------------------------------------------------------------------------
54.4(a)(3)                           100                     1                 100               20        2,000
----------------------------------------------------------------------------------------------------------------
54.4                              46,000                  0.25              11,500                1       11,500
----------------------------------------------------------------------------------------------------------------
Total               ....................  ....................  ..................  ...............       18,500
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The sponsors of covered studies will be required to 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. This 
time is consistent with the current recordkeeping requirements for 
other information related to marketing applications for human drugs, 
biologics, and medical devices. Currently, sponsors of covered studies 
must maintain many records with 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 clinical investigators' file.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency per     Total Annual        Hours per
 21 CFR Section  No. of Recordkeepers      Recordkeeping           Records            Record        Total Hours
----------------------------------------------------------------------------------------------------------------
54.6                            1,000                     1               1,000             0.25          250
----------------------------------------------------------------------------------------------------------------
Total            ....................  ....................  ..................  ...............          250
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 79495]]

    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30837 Filed 12-24-08; 8:45 am]
BILLING CODE 4160-01-S