81 FR 75826 - Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 211 (November 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 211 (November 1, 2016)
| Page Range | 75826-75827 | |
| FR Document | 2016-26258 |
[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)] [Notices] [Pages 75826-75827] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26258] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1163] Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards 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 the recordkeeping requirements for institutional review boards (IRBs). DATES: Submit either electronic or written comments on the collection of information by January 3, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N-1163 for ``Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS [[Page 75827]] CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown Street, 10A63, North Bethesda, MD 20852, [email protected]. 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. Institutional Review Boards--21 CFR 56.115 OMB Control Number 0910-0130--Extension When reviewing clinical research studies regulated by FDA, institutional review boards (IRBs) are required to create and maintain records describing their operations, and make the records available for FDA inspection when requested. These records include: Written procedures describing the structure and membership of the IRB and the methods that the IRB will use in performing its functions; the research protocols, informed consent documents, progress reports, and reports of injuries to subjects submitted by investigators to the IRB; minutes of meetings showing attendance, votes, and decisions made by the IRB; the number of votes on each decision for, against, and abstaining; the basis for requiring changes in or disapproving research; records of continuing review activities; copies of all correspondence between investigators and the IRB; statement of significant new findings provided to subjects of the research; a list of IRB members by name, showing each member's earned degrees, representative capacity, and experience in sufficient detail to describe each member's contributions to the IRB's deliberations; and any employment relationship between each member and the IRB's institution. This information is used by FDA in conducting audit inspections of IRBs to determine whether IRBs and clinical investigators are providing adequate protections to human subjects participating in clinical research. The recordkeeping requirement burden is based on the following information; the burden for the paragraphs under 21 CFR 56.115 has been considered as one estimated burden. This burden estimate assumes that there are approximately 2,520 IRBs, that each IRB meets on an average of 14.6 times annually, and that approximately 100 hours of person-time per meeting are required to meet the requirements of the regulation. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR Section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeper -------------------------------------------------------------------------------------------------------------------------------------------------------- 56.115........................................................ 2,520 14.6 36,792 100 3,679,200 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26258 Filed 10-31-16; 8:45 am] BILLING CODE 4164-01-P
![75826 Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Notices
reasonably be expected from, and are with FDA’s decision regarding the Since 1992, 20 requests for revision of
ordinarily exercised by, a person during petition may, under § 60.40 (21 CFR the regulatory review period have been
a regulatory review period. As provided 60.40), request an informal hearing for submitted under § 60.24(a). For 2013,
in § 60.30(c), a due diligence petition reconsideration of the due diligence 2014 and 2015, a total of 5 requests have
‘‘shall set forth sufficient facts, determination. Petitioners are likely to been submitted under § 60.24(a). During
including dates if possible, to merit an include persons or organizations having that same time period, there have been
investigation by FDA of whether the knowledge that FDA’s marketing no requests under §§ 60.30 and 60.40;
applicant acted with due diligence.’’ permission for that product was not however, for purposes of this
Upon receipt of a due diligence petition, actively pursued throughout the information collection approval, we are
FDA reviews the petition and evaluates
regulatory review period. The estimating that we may receive one
whether any change in the regulatory
information collection for which an submission annually.
review period if necessary. If so, the
corrected regulatory review period is extension of approval is being sought is FDA estimates the burden of this
published in the Federal Register. A the use of the statutorily created due collection of information as follows:
due diligence petitioner not satisfied diligence petition.
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
60.24(a) ................................................................................ 3 1.66 5 100 500
60.30 .................................................................................... 1 1 1 50 50
60.40 .................................................................................... 1 1 1 10 10
Total .............................................................................. ........................ ........................ ........................ ........................ 560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 27, 2016. DATES: Submit either electronic or Written/Paper Submissions
Leslie Kux, written comments on the collection of Submit written/paper submissions as
Associate Commissioner for Policy. information by January 3, 2017. follows:
[FR Doc. 2016–26322 Filed 10–31–16; 8:45 am]
ADDRESSES: You may submit comments • Mail/Hand delivery/Courier (for
BILLING CODE 4164–01–P as follows: written/paper submissions): Division of
Dockets Management (HFA–305), Food
Electronic Submissions and Drug Administration, 5630 Fishers
DEPARTMENT OF HEALTH AND Lane, Rm. 1061, Rockville, MD 20852.
HUMAN SERVICES Submit electronic comments in the
• For written/paper comments
following way:
submitted to the Division of Dockets
Food and Drug Administration • Federal eRulemaking Portal: http:// Management, FDA will post your
www.regulations.gov. Follow the comment, as well as any attachments,
[Docket No. FDA–2013–N–1163] instructions for submitting comments. except for information submitted,
Comments submitted electronically, marked and identified, as confidential,
Agency Information Collection including attachments, to http:// if submitted as detailed in
Activities: Proposed Collection; www.regulations.gov will be posted to ‘‘Instructions.’’
Comment Request; Institutional
the docket unchanged. Because your Instructions: All submissions received
Review Boards
comment will be made public, you are must include the Docket No. FDA–
AGENCY: Food and Drug Administration, solely responsible for ensuring that your 2013–N–1163 for ‘‘Agency Information
HHS. comment does not include any Collection Activities: Proposed
confidential information that you or a Collection; Comment Request;
ACTION: Notice. third party may not wish to be posted, Institutional Review Boards.’’ Received
such as medical information, your or comments will be placed in the docket
SUMMARY: The Food and Drug anyone else’s Social Security number, or and, except for those submitted as
Administration (FDA) is announcing an confidential business information, such ‘‘Confidential Submissions,’’ publicly
opportunity for public comment on the as a manufacturing process. Please note viewable at http://www.regulations.gov
proposed collection of certain that if you include your name, contact or at the Division of Dockets
information by the Agency. Under the information, or other information that Management between 9 a.m. and 4 p.m.,
Paperwork Reduction Act of 1995 (the Monday through Friday.
identifies you in the body of your
PRA), Federal Agencies are required to • Confidential Submissions—To
comments, that information will be
publish notice in the Federal Register submit a comment with confidential
asabaliauskas on DSK3SPTVN1PROD with NOTICES
posted on http://www.regulations.gov.
concerning each proposed collection of information that you do not wish to be
information, including each proposed • If you want to submit a comment made publicly available, submit your
extension of an existing collection of with confidential information that you comments only as a written/paper
information, and to allow 60 days for do not wish to be made available to the submission. You should submit two
public comment in response to the public, submit the comment as a copies total. One copy will include the
notice. This notice solicits comments on written/paper submission and in the information you claim to be confidential
the recordkeeping requirements for manner detailed (see ‘‘Written/Paper with a heading or cover note that states
institutional review boards (IRBs). Submissions’’ and ‘‘Instructions’’). ‘‘THIS DOCUMENT CONTAINS
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![Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Notices 75827
CONFIDENTIAL INFORMATION.’’ The information they conduct or sponsor. available for FDA inspection when
Agency will review this copy, including ‘‘Collection of information’’ is defined requested. These records include:
the claimed confidential information, in in 44 U.S.C. 3502(3) and 5 CFR Written procedures describing the
its consideration of comments. The 1320.3(c) and includes Agency requests structure and membership of the IRB
second copy, which will have the or requirements that members of the and the methods that the IRB will use
claimed confidential information public submit reports, keep records, or in performing its functions; the research
redacted/blacked out, will be available provide information to a third party. protocols, informed consent documents,
for public viewing and posted on http:// Section 3506(c)(2)(A) of the PRA (44 progress reports, and reports of injuries
www.regulations.gov. Submit both U.S.C. 3506(c)(2)(A)) requires Federal to subjects submitted by investigators to
copies to the Division of Dockets Agencies to provide a 60-day notice in the IRB; minutes of meetings showing
Management. If you do not wish your the Federal Register concerning each attendance, votes, and decisions made
name and contact information to be proposed collection of information, by the IRB; the number of votes on each
made publicly available, you can including each proposed extension of an
decision for, against, and abstaining; the
provide this information on the cover existing collection of information,
basis for requiring changes in or
sheet and not in the body of your before submitting the collection to OMB
comments and you must identify this for approval. To comply with this disapproving research; records of
information as ‘‘confidential.’’ Any requirement, FDA is publishing notice continuing review activities; copies of
information marked as ‘‘confidential’’ of the proposed collection of all correspondence between
will not be disclosed except in information set forth in this document. investigators and the IRB; statement of
accordance with 21 CFR 10.20 and other With respect to the following significant new findings provided to
applicable disclosure law. For more collection of information, FDA invites subjects of the research; a list of IRB
information about FDA’s posting of comments on these topics: (1) Whether members by name, showing each
comments to public dockets, see 80 FR the proposed collection of information member’s earned degrees, representative
56469, September 18, 2015, or access is necessary for the proper performance capacity, and experience in sufficient
the information at: http://www.fda.gov/ of FDA’s functions, including whether detail to describe each member’s
regulatoryinformation/dockets/ the information will have practical contributions to the IRB’s deliberations;
default.htm. utility; (2) the accuracy of FDA’s and any employment relationship
Docket: For access to the docket to estimate of the burden of the proposed between each member and the IRB’s
read background documents or the collection of information, including the institution. This information is used by
electronic and written/paper comments validity of the methodology and FDA in conducting audit inspections of
received, go to http:// assumptions used; (3) ways to enhance IRBs to determine whether IRBs and
www.regulations.gov and insert the the quality, utility, and clarity of the clinical investigators are providing
docket number, found in brackets in the information to be collected; and (4) adequate protections to human subjects
heading of this document, into the ways to minimize the burden of the participating in clinical research.
‘‘Search’’ box and follow the prompts collection of information on
and/or go to the Division of Dockets respondents, including through the use The recordkeeping requirement
Management, 5630 Fishers Lane, Rm. of automated collection techniques, burden is based on the following
1061, Rockville, MD 20852. when appropriate, and other forms of information; the burden for the
FOR FURTHER INFORMATION CONTACT: FDA information technology. paragraphs under 21 CFR 56.115 has
PRA Staff, Office of Operations, Food been considered as one estimated
Institutional Review Boards—21 CFR burden. This burden estimate assumes
and Drug Administration, Three White 56.115
Flint North, 11601 Landsdown Street, that there are approximately 2,520 IRBs,
10A63, North Bethesda, MD 20852, OMB Control Number 0910–0130— that each IRB meets on an average of
PRAStaff@fda.hhs.gov. Extension 14.6 times annually, and that
SUPPLEMENTARY INFORMATION: Under the When reviewing clinical research approximately 100 hours of person-time
PRA (44 U.S.C. 3501–3520), Federal studies regulated by FDA, institutional per meeting are required to meet the
Agencies must obtain approval from the review boards (IRBs) are required to requirements of the regulation.
Office of Management and Budget create and maintain records describing FDA estimates the burden of this
(OMB) for each collection of their operations, and make the records collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeper
56.115 ........................................................................ 2,520 14.6 36,792 100 3,679,200
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 26, 2016.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–26258 Filed 10–31–16; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2016-11-01 02:35:57
Document Modified: 2016-11-01 02:35:57
| 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 | Submit either electronic or written comments on the collection of information by January 3, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown Street, 10A63, North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 75826 |
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