Agency Information Collection Activities: Proposed Collection; Comment Request; Institutional Review Boards, 60286-60287 [2013-23864]

Download as PDF 60286 Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES system will be given credentials to use OLDC. Upon request, ACF will provide credentials and access to use the OLDC system to all applicants and grantees. Individuals already authorized to use OLDC may need their authorization updated to include additional programs or documents, if applicable. Affected ACF Program Offices will send detailed instructions to grantees and applicants. 7. The same commenter also asked whether submitted State Plans could be viewed by the public through ACF’s OLDC system. ACF responds that the OLDC system does not have the capability to allow viewing of submitted plans or reports by the public. ACF Program Offices that provide public viewing of submitted plans on their Web sites will continue that practice. States and Tribes should follow their internal procedures in making the determination to provide plans and reports for public viewing. 8. A commenter objected to the requirement by some ACF Program Offices that a paper copy of a submitted plan be distributed to the relevant ACF Regional Office. The same commenter also recommended that, once a plan is electronically signed and submitted to OLDC, ACF should not allow subsequent changes to the data unless the grantee is submitting a revised report, according to the reporting instructions. ACF responds that, with the implementation of this requirement, once a grantee submits its plan or reporting forms into OLDC, the submission of a second paper copy is no longer required. ACF’s Regional Office staff will access plans and reports using OLDC, eliminating the requirement for distribution of additional copies. And, we note that once a submission is signed and submitted in OLDC, any revisions, changes, or updates must be made by entering a revised report in OLDC. We note that there is no limit to the number of revised reports a grantee may submit; however, some date restrictions by the cognizant Program Office may apply to submission of revisions. Statutory Authority: Financial Assistance Management Improvement Act of 1999, Pub. L. 106–107. Robert Noonan, Deputy Assistant Secretary for Administration, Administration for Children and Families. [FR Doc. 2013–23773 Filed 9–30–13; 8:45 am] BILLING CODE 4184–01–P VerDate Mar<15>2010 14:45 Sep 30, 2013 Jkt 232001 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. 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 December 2, 2013. 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. 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, SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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 Part 56.115 (OMB Control Number 0910–0130)—Extension When reviewing clinical research studies regulated by FDA, IRBs are required to create and maintain records describing their operations, and make the records available for FDA inspection when requested. These records include: (1) Written procedures describing the structure and membership of the IRB and the methods that the IRB will use in performing its functions; (2) the research protocols, informed consent documents, progress reports, and reports of injuries to subjects submitted by investigators to the IRB; (3) 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; (4) records of continuing review activities; copies of all correspondence between investigators and the IRB; (5) statement of significant new findings provided to subjects of the research; and (6) 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. E:\FR\FM\01OCN1.SGM 01OCN1 Federal Register / Vol. 78, No. 190 / Tuesday, October 1, 2013 / Notices The recordkeeping requirement burden is based on the following: The burden for each of the paragraphs under 21 CFR 56.115 has been considered as one estimated burden. FDA estimates that there are approximately 2,500 IRBs. The IRBs meet on an average of 14.6 times annually. The Agency estimates that approximately 100 hours of person- 60287 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 21 CFR Section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 56.115 .................................................................................. 2,500 14.6 36,500 100 3,650,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 25, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–23864 Filed 9–30–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1164] Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Biological Products 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 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 communication studies involving biological products that are regulated by FDA. DATES: Submit either electronic or written comments on the collection of information by December 2, 2013. 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 emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:45 Sep 30, 2013 Jkt 232001 comments should be identified with the 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, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. 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. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Testing Communications on Biological Products—(OMB Control Number 0910– 0687)—Extension FDA is authorized by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 393(d)(2)(D)) to conduct educational and public information programs relating to the safety of regulated biological products. FDA conducts needed research to help ensure that such programs have the highest likelihood of being effective. FDA expects that improving communications about biological products will involve many research methods, including individual in-depth interviews, mallintercept interviews, focus groups, selfadministered surveys, gatekeeper reviews, and omnibus telephone surveys. The information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency’s mission to protect the public health. The information collected will serve three major purposes. First, as formative research it will provide critical knowledge needed about target audiences to develop messages and campaigns about biological product use. Knowledge of consumer and healthcare professional decision-making processes will provide the better understanding of target audiences that FDA needs to design effective communication strategies, messages, and labels. These communications will aim to improve public understanding of the risks and benefits of using biological products by providing users with a better context in which to place risk information more completely. Second, as initial testing, it will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Testing messages with a sample of the target audience will allow FDA to refine messages while still in the E:\FR\FM\01OCN1.SGM 01OCN1

Agencies

[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60286-60287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23864]


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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 December 2, 2013.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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 Part 56.115 (OMB Control Number 
0910-0130)--Extension

    When reviewing clinical research studies regulated by FDA, IRBs are 
required to create and maintain records describing their operations, 
and make the records available for FDA inspection when requested. These 
records include: (1) Written procedures describing the structure and 
membership of the IRB and the methods that the IRB will use in 
performing its functions; (2) the research protocols, informed consent 
documents, progress reports, and reports of injuries to subjects 
submitted by investigators to the IRB; (3) 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; (4) records of continuing review 
activities; copies of all correspondence between investigators and the 
IRB; (5) statement of significant new findings provided to subjects of 
the research; and (6) 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.

[[Page 60287]]

    The recordkeeping requirement burden is based on the following: The 
burden for each of the paragraphs under 21 CFR 56.115 has been 
considered as one estimated burden. FDA estimates that there are 
approximately 2,500 IRBs. The IRBs meet on an average of 14.6 times 
annually. The Agency estimates 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       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
56.115.............................................................           2,500             14.6           36,500              100        3,650,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23864 Filed 9-30-13; 8:45 am]
BILLING CODE 4160-01-P