80 FR 66542 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 209 (October 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 209 (October 29, 2015)
| Page Range | 66542-66543 | |
| FR Document | 2015-27559 |
[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)] [Notices] [Pages 66542-66543] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27559] [[Page 66542]] ----------------------------------------------------------------------- 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 November 30, 2015. 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 [email protected]. 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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 regard to clinical investigators, including protocol agreements and investigator r[eacute]sum[eacute]s 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. In the Federal Register of April 29, 2015 (80 FR 23803), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although two comments were received, none were responsive to the four collection of information topics solicited and therefore will not be discussed in this document. 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 1,000 1 1,000 1 1,000 (a)(2)--Form FDA 3454.......... Disclosure--54.4(a)(3)--Form FDA 100 1 100 5 500 3455........................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,500 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of records Total annual 21 CFR Section recordkeepers per recordkeeper records Average burden per recordkeeping Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Recordkeeping--54.6...................... 1,000 1 1,000 0.25 250 (15 minutes)..................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 66543]] Table 3--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of disclosures Total annual Average burden per disclosure Total hours respondents per respondent disclosures -------------------------------------------------------------------------------------------------------------------------------------------------------- 54.4(b)--Clinical Investigators................ 7,106 1 7,106 0.17 1,208 (10 minutes)........................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27559 Filed 10-28-15; 8:45 am] BILLING CODE 4164-01-P
![66542 Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
DEPARTMENT OF HEALTH AND and Drug Administration, 8455 information showing any financial
HUMAN SERVICES Colesville Rd., COLE–14526, Silver interests held by the clinical
Spring, MD 20993–0002, PRAStaff@ investigator, for a time period of 2 years
Food and Drug Administration fda.hhs.gov. after the date of approval of the
[Docket No. FDA–2012–N–0280] SUPPLEMENTARY INFORMATION: In applications. Sponsors of covered
compliance with 44 U.S.C. 3507, FDA studies maintain many records with
Agency Information Collection has submitted the following proposed regard to clinical investigators,
Activities; Submission for Office of collection of information to OMB for including protocol agreements and
Management and Budget Review; review and clearance. investigator résumés or curriculum
Comment Request; Financial vitae. FDA estimates than an average of
Disclosure by Clinical Investigators Financial Disclosure by Clinical 15 minutes will be required for each
Investigators OMB Control Number recordkeeper to add this record to the
AGENCY: Food and Drug Administration, 0910–0396—Extension clinical investigators’ file.
HHS.
Respondents to this collection are Under § 54.4(b), clinical investigators
ACTION: Notice. sponsors of marketing applications that supply to the sponsor of a covered study
SUMMARY: The Food and Drug contain clinical data from studies financial information sufficient to allow
Administration (FDA) is announcing covered by the regulations. These the sponsor to submit complete and
that a proposed collection of sponsors represent pharmaceutical, accurate certification or disclosure
information has been submitted to the biologic, and medical device firms. statements. Clinical investigators are
Office of Management and Budget Respondents are also clinical accustomed to supplying such
(OMB) for review and clearance under investigators who provide financial information when applying for research
the Paperwork Reduction Act of 1995. information to the sponsors of grants. Also, most people know the
DATES: Fax written comments on the
marketing applications. financial holdings of their immediate
Under § 54.4(a) (21 CFR 54.4(a)), family and records of such interests are
collection of information by November
applicants submitting an application generally accessible because they are
30, 2015.
that relies on clinical studies must needed for preparing tax records. For
ADDRESSES: To ensure that comments on
submit a complete list of clinical these reasons, FDA estimates that it will
the information collection are received, investigators who participated in a
OMB recommends that written take clinical investigators 15 minutes to
covered clinical study, and must either submit such records to the sponsor.
comments be faxed to the Office of certify to the absence of certain financial
Information and Regulatory Affairs, arrangements with clinical investigators In the Federal Register of April 29,
OMB, Attn: FDA Desk Officer, FAX: (Form FDA 3454) or, under § 54.4(a)(3), 2015 (80 FR 23803), FDA published a
202–395–7285, or emailed to oira_ disclose to FDA the nature of those 60-day notice requesting public
submission@omb.eop.gov. All arrangements and the steps taken by the comment on the proposed collection of
comments should be identified with the applicant or sponsor to minimize the information. Although two comments
OMB control number 0910–0396. Also potential for bias (Form FDA 3455). were received, none were responsive to
include the FDA docket number found Under § 54.6, the sponsors of covered the four collection of information topics
in brackets in the heading of this studies must maintain complete records solicited and therefore will not be
document. of compensation agreements with any discussed in this document.
FOR FURTHER INFORMATION CONTACT: FDA compensation paid to nonemployee FDA estimates the burden of this
PRA Staff, Office of Operations, Food clinical investigators, including collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent response
Certification—54.4(a)(1) and (a)(2)—Form FDA 3454 ........ 1,000 1 1,000 1 1,000
Disclosure—54.4(a)(3)—Form FDA 3455 ........................... 100 1 100 5 500
Total .............................................................................. ........................ ........................ ........................ ........................ 1,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average burden
Number of record- Number of records Total annual
21 CFR Section per record- Total hours
keepers per recordkeeper records keeping
Recordkeeping—54.6 ............................... 1,000 1 1,000 0.25 250
asabaliauskas on DSK5VPTVN1PROD with NOTICES
(15 minutes) .....
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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![Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices 66543
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of dis-
Number of Total annual Average burden
21 CFR Section closures per Total hours
respondents disclosures per disclosure
respondent
54.4(b)—Clinical Investigators .......................................... 7,106 1 7,106 0.17 1,208
(10 minutes) .....
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 23, 2015. OMB control number 0910–0802. The instructions for submitting comments.
Leslie Kux, approval expires on September 30, Comments submitted electronically,
Associate Commissioner for Policy. 2018. A copy of the supporting including attachments, to http://
[FR Doc. 2015–27559 Filed 10–28–15; 8:45 am] statement for this information collection www.regulations.gov will be posted to
BILLING CODE 4164–01–P is available on the Internet at http:// the docket unchanged. Because your
www.reginfo.gov/public/do/PRAMain. comment will be made public, you are
Dated: October 23, 2015. solely responsible for ensuring that your
DEPARTMENT OF HEALTH AND Leslie Kux, comment does not include any
HUMAN SERVICES confidential information that you or a
Associate Commissioner for Policy.
third party may not wish to be posted,
Food and Drug Administration [FR Doc. 2015–27558 Filed 10–28–15; 8:45 am]
such as medical information, your or
BILLING CODE 4164–01–P
[Docket No. FDA–2013–D–0286] anyone else’s Social Security number, or
confidential business information, such
Agency Information Collection as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND
Activities; Announcement of Office of that if you include your name, contact
HUMAN SERVICES
Management and Budget Approval; information, or other information that
Guidance for Industry on Formal Food and Drug Administration identifies you in the body of your
Meetings Between the Food and Drug comments, that information will be
Administration and Biosimilar [Docket No. FDA–2015–N–3579] posted on http://www.regulations.gov.
Biological Product Sponsors or • If you want to submit a comment
Using Technologies and Innovative
Applicants with confidential information that you
Methods To Conduct Food and Drug
do not wish to be made available to the
AGENCY: Food and Drug Administration, Administration-Regulated Clinical
public, submit the comment as a
HHS. Investigations of Investigational
written/paper submission and in the
ACTION: Notice. Drugs; Establishment of a Public
manner detailed (see ‘‘Written/Paper
Docket
SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
Administration (FDA) is announcing AGENCY: Food and Drug Administration, Written/Paper Submissions
that a collection of information entitled HHS.
ACTION: Notice; establishment of docket; Submit written/paper submissions as
‘‘Guidance for Industry on Formal
request for comments. follows:
Meetings Between the Food and Drug
• Mail/Hand delivery/Courier (for
Administration and Biosimilar
SUMMARY: The Food and Drug written/paper submissions): Division of
Biological Product Sponsors or
Administration (FDA or Agency) is Dockets Management (HFA–305), Food
Applicant’’ has been approved by the
announcing the establishment of a and Drug Administration, 5630 Fishers
Office of Management and Budget
public docket to solicit input from a Lane, rm. 1061, Rockville, MD 20852.
(OMB) under the Paperwork Reduction
broad group of stakeholders on the • For written/paper comments
Act of 1995.
scope and direction of the use of submitted to the Division of Dockets
FOR FURTHER INFORMATION CONTACT: FDA technologies and innovative methods in Management, FDA will post your
PRA Staff, Office of Operations, Food the conduct of clinical investigations. comment, as well as any attachments,
and Drug Administration, 8455 Specifically, FDA seeks information to except for information submitted,
Colesville Rd., COLE–14526, Silver understand individual and industry marked and identified, as confidential,
Spring, MD 20993–0002, PRAStaff@ experiences with the use of such if submitted as detailed in
fda.hhs.gov. technologies to more efficiently conduct ‘‘Instructions.’’
SUPPLEMENTARY INFORMATION: On June clinical research. FDA also seeks Instructions: All submissions received
25, 2015, the Agency submitted a stakeholder perspectives on possible must include the Docket No. FDA–
proposed collection of information barriers to implementing these 2015–N–3579 for ‘‘Using Technologies
entitled ‘‘Guidance for Industry on technologies and methods to conduct and Innovative Methods to Conduct
Formal Meetings Between the Food and clinical investigations. FDA-Regulated Clinical Investigations
Drug Administration and Biosimilar DATES: Submit electronic or written of Investigational Drugs.’’ Please
Biological Product Sponsors or identify the specific question or issue
asabaliauskas on DSK5VPTVN1PROD with NOTICES
comments by December 28, 2015.
Applicant’’ to OMB for review and ADDRESSES: You may submit comments that the comment addresses. Received
clearance under 44 U.S.C. 3507. An as follows: comments will be placed in the docket
Agency may not conduct or sponsor, and, except for those submitted as
and a person is not required to respond Electronic Submissions ‘‘Confidential Submissions,’’ publicly
to, a collection of information unless it Submit electronic comments in the viewable at http://www.regulations.gov
displays a currently valid OMB control following way: or at the Division of Dockets
number. OMB has now approved the • Federal eRulemaking Portal: http:// Management between 9 a.m. and 4 p.m.,
information collection and has assigned www.regulations.gov. Follow the Monday through Friday.
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Document Created: 2015-12-14 15:22:05
Document Modified: 2015-12-14 15:22:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by November 30, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 66542 |
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