82 FR 19056 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 78 (April 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 78 (April 25, 2017)
| Page Range | 19056-19057 | |
| FR Document | 2017-08327 |
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)] [Notices] [Pages 19056-19057] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08327] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1163] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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 (PRA). DATES: Fax written comments on the collection of information by May 25, 2017. 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 0910-0130. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For specific questions for FDA related to this document, contact JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. SUPPLEMENTARY INFORMATION: 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; and 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: The burden for the paragraphs under 21 CFR 56.115 has been considered as one [[Page 19057]] 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. In the Federal Register of November 1, 2016 (81 FR 75826), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received in response to the notice. FDA estimates the burden of this collection as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR part 56; subpart D; records and reports Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- 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: April 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-08327 Filed 4-24-17; 8:45 am] BILLING CODE 4164-01-P
![19056 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
Total .............................................................................. ........................ ........................ ........................ ........................ 517,849
1 There are no capital costs or operating maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Average
Number of
Number of Total annual burden per
21 CFR Section records per Total hours
recordkeepers records recordkeeping
recordkeeper (in hours)
58.29(b); Personnel .............................................. 300 20 6,000 0.21 (13 minutes) ......... 1,260
58.35(b)(1)–(6), and (c); Quality assurance unit .. 300 270.76 81,228 3.36 ............................... 272,926
58.63(b) and (c); Maintenance and calibration of 300 60 18,000 0.09 (5 minutes) ........... 1,620
equipment.
58.81(a)–(c); SOPs ............................................... 300 301.8 90,540 0.14 (8 minutes) ........... 12,676
58.90(c) and (g); Animal care .............................. 300 62.7 18,810 0.13 (8 minutes) ........... 2,445
58.105(a) and (b); Test and control article char- 300 5 1,500 11.8 ............................... 17,700
acterization.
58.107(d); Test and control article handling ........ 300 1 300 4.25 ............................... 1,275
58.113(a); Mixtures of articles with carriers ......... 300 15.33 4,599 6.8 ................................. 31,273
58.120; Protocol ................................................... 300 15.38 4,614 32.7 ............................... 150,878
58.195; Retention of records ................................ 300 251.5 75,450 3.9 ................................. 294,255
Total ............................................................... ........................ ........................ ........................ ....................................... 786,308
1There are no capital costs or operating and maintenance costs associated with this collection of information.
The annual burden for the the Paperwork Reduction Act of 1995 available for FDA inspection when
information collection requirements in (PRA). requested. These records include:
these regulations is estimated at Written procedures describing the
DATES: Fax written comments on the
1,304,157 burden hours (517,849 plus structure and membership of the IRB
collection of information by May 25,
786,308 equals 1,304,157). The hours and the methods that the IRB will use
2017.
per response estimates are based on our in performing its functions; the research
experience with similar programs and ADDRESSES: To ensure that comments on protocols, informed consent documents,
information received from industry. the information collection are received, progress reports, and reports of injuries
Dated: April 19, 2017. OMB recommends that written to subjects submitted by investigators to
Anna K. Abram,
comments be faxed to the Office of the IRB; minutes of meetings showing
Information and Regulatory Affairs, attendance, votes, and decisions made
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. OMB, Attn: FDA Desk Officer, FAX: by the IRB, the number of votes on each
202–395–7285, or emailed to oira_ decision for, against, and abstaining; the
[FR Doc. 2017–08304 Filed 4–24–17; 8:45 am]
submission@omb.eop.gov. All basis for requiring changes in or
BILLING CODE 4164–01–P
comments should be identified with the disapproving research; records of
OMB control number 0910–0130. Also continuing review activities; copies of
DEPARTMENT OF HEALTH AND include the FDA docket number found all correspondence between
HUMAN SERVICES in brackets in the heading of this investigators and the IRB; statement of
document. significant new findings provided to
Food and Drug Administration FOR FURTHER INFORMATION CONTACT: For subjects of the research; and a list of IRB
[Docket No. FDA–2013–N–1163] specific questions for FDA related to members by name, showing each
this document, contact JonnaLynn member’s earned degrees, representative
Agency Information Collection Capezzuto, Office of Operations, Food capacity, and experience in sufficient
Activities; Submission for Office of and Drug Administration, Three White detail to describe each member’s
Management and Budget Review; Flint North, 10A63, 11601 Landsdown contributions to the IRB’s deliberations;
Comment Request; Institutional St., North Bethesda, MD 20852, 301– and any employment relationship
Review Boards 796–3794. between each member and the IRB’s
SUPPLEMENTARY INFORMATION:
institution. This information is used by
AGENCY: Food and Drug Administration, FDA in conducting audit inspections of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
HHS. Institutional Review Boards—21 CFR IRBs to determine whether IRBs and
ACTION: Notice. 56.115—OMB Control Number 0910– clinical investigators are providing
SUMMARY: The Food and Drug 0130—Extension adequate protections to human subjects
Administration (FDA or we) is When reviewing clinical research participating in clinical research.
announcing that a proposed collection studies regulated by FDA, institutional The recordkeeping requirement
of information has been submitted to the review boards (IRBs) are required to burden is based on the following: The
Office of Management and Budget create and maintain records describing burden for the paragraphs under 21 CFR
(OMB) for review and clearance under their operations, and make the records 56.115 has been considered as one
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![Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19057
estimated burden. This burden estimate per meeting are required to meet the this collection of information. No
assumes that there are approximately requirements of the regulation. comments were received in response to
2,520 IRBs, that each IRB meets on an In the Federal Register of November the notice.
average of 14.6 times annually, and that 1, 2016 (81 FR 75826), we published a
FDA estimates the burden of this
approximately 100 hours of person-time 60-day notice requesting public
collection as follows:
comment on the proposed extension of
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR part 56; subpart D; records and reports records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
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: April 19, 2017. MD 20993–0002. For those unable to Dockets Management (HFA–305), Food
Anna K. Abram, attend in person, the meeting will also and Drug Administration, 5630 Fishers
Deputy Commissioner for Policy, Planning, be webcast. The link for the webcast is Lane, Rm. 1061, Rockville, MD 20852.
Legislation, and Analysis. available at https:// • For written/paper comments
[FR Doc. 2017–08327 Filed 4–24–17; 8:45 am] collaboration.fda.gov/pacm051817. submitted to the Division of Dockets
BILLING CODE 4164–01–P Answers to commonly asked questions Management, FDA will post your
including information regarding special comment, as well as any attachments,
accommodations due to a disability, except for information submitted,
DEPARTMENT OF HEALTH AND visitor parking, and transportation may marked and identified, as confidential,
HUMAN SERVICES be accessed at http://www.fda.gov/ if submitted as detailed in
AdvisoryCommittees/ ‘‘Instructions.’’
Food and Drug Administration AboutAdvisoryCommittees/ Instructions: All submissions received
[Docket No. FDA 2017–N–1780]
ucm408555.htm. must include the Docket No. FDA 2017–
You may submit your comments as N–1780 for the ‘‘Joint Meeting of the
Joint Meeting of the Pediatric Advisory follows: Pediatric Advisory Committee and the
Committee and the Pediatric Ethics Electronic Submissions Pediatric Ethics Subcommittee; Notice
Subcommittee; Notice of Meeting; of Meeting; Establishment of a Public
Submit electronic comments in the Docket; Request for Comments.’’
Establishment of a Public Docket;
following way:
Request for Comments Received comments will be placed in
• Federal eRulemaking Portal:
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AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the
instructions for submitting comments. submitted as ‘‘Confidential
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Comments submitted electronically,
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including attachments, to https://
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the docket unchanged. Because your
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Administration (FDA or Agency) solely responsible for ensuring that your
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DATES: The meeting will be held on May
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• If you want to submit a comment its consideration of comments. The
18, 2017, from 8:30 a.m. to 5:30 p.m. second copy, which will have the
with confidential information that you
The docket number is FDA 2017–N– claimed confidential information
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1780. The docket will close on May 19, redacted/blacked out, will be available
public, submit the comment as a
2017. Comments received on or before for public viewing and posted on
asabaliauskas on DSK3SPTVN1PROD with NOTICES
written/paper submission and in the
May 5, 2017 will be provided to the https://www.regulations.gov. Submit
manner detailed (see ‘‘Written/Paper
committee. Comments received after the both copies to the Division of Dockets
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Document Created: 2017-04-25 02:18:24
Document Modified: 2017-04-25 02:18:24
| 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 May 25, 2017. | |
| Contact | For specific questions for FDA related to this document, contact JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. | |
| FR Citation | 82 FR 19056 |
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