Proposed Information Collection Activity; Comment Request, 68452-68453 [2013-27221]

Download as PDF 68452 Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalization will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. The Agency received no comments in response to the 60-day notice published in the Federal Register on December 22, 2010 (75 FR 80542). This is a new collection of information. Individual respondents can participate in the telephone survey voluntary. Below we provide CDC’s projected annualized estimate for next three years. There is no cost to respondents other than their time. The estimated annualized burden hours for this data collection activity are 4,000. ESTIMATED ANNUALIZED BURDEN HOURS Type of collection Average number of respondents Annual frequency per response Average number of activities Average hours per response Interactive Voice Surveys, Online Surveys ..................................................... 60,000 1 1 4/60 Kimberly S. Lane, Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2013–27275 Filed 11–13–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: ACF Program Instruction: Children’s Justice Act. OMB No.: 0980–0196. Description: The Program Instruction, prepared in response to the enactment of the Childrens Justice Act (CJA), Title II of Public Law. 111–320, Child Abuse Prevention and Treatment Act Reauthorization of 2010, provides direction to the States and Territories to accomplish the purposes of assisting States in developing, establishing and operating programs designed to improve: (1) The assessment and investigation of suspected child abuse and neglect cases, including cases of suspected child sexual abuse and exploitation, in a manner that limits additional trauma to the child and the child’s family; (2) the assessment and investigation of cases of suspected child abuse-related fatalities and suspected child neglect-related fatalities; (3) the investigation and prosecution of cases of child abuse and neglect, including child sexual abuse and exploitation; and (4) the assessment and investigation of cases involving children with disabilities or serious health-related problems who are suspected victims of child abuse or neglect. This Program Instruction contains information collection requirements that are found in P. L. 111–320 at Sections 107(b) and 107(d), and pursuant to receiving a grant award. The information being collected is required by statute to be submitted pursuant to receiving a grant award. The information submitted will be used by the agency to ensure compliance with the statute; to monitor, evaluate and measure grantee achievements in addressing the investigation and prosecution of child abuse and neglect; and to report to Congress. Respondents: State Governments ANNUAL BURDEN ESTIMATES Number of respondents Instrument Application & Annual Report ........................................................................... Number of responses per respondent 52 1 TKELleY on DSK3SPTVN1PROD with NOTICES Estimated total annual burden hours ....................................................... In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and VerDate Mar<15>2010 19:20 Nov 13, 2013 Jkt 232001 Frm 00043 Fmt 4703 Sfmt 4703 60 Total burden hours 3,120 3,120 Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: infocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary PO 00000 Average burden hours per response for the proper performance of the functions of the agency, including whether the information shall have 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 E:\FR\FM\14NON1.SGM 14NON1 Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices 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. Robert Sargis, Reports Clearance Officer. [FR Doc. 2013–27221 Filed 11–13–13; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1152] Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) 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 invites comments on the information collection provisions of our existing regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients. DATES: Submit either electronic or written comments on the collection of information by January 13, 2014. 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 TKELleY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:20 Nov 13, 2013 Jkt 232001 Dr., PI50–400B, Rockville, MD 20850, 301–796–3793, 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. Petition To Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements—21 CFR 111.75(a)(1)(ii) (OMB Control Number 0910–0608)— Extension The Dietary Supplement Health and Education Act (Pub. L. 103–417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services (the Secretary) may, by regulation, prescribe good manufacturing practices for dietary supplements. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if ‘‘it has PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 68453 been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.’’ Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives us the authority to issue regulations for the efficient enforcement of the FD&C Act. Part 111 of our regulations (21 CFR part 111) establishes the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Section 111.75(a)(1) of our regulations (21 CFR 111.75(a)(1)) establishes a procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients. According to § 111.75(a)(1)(ii), manufacturers may request an exemption from the requirements set forth in § 111.75(a)(1)(i) when the dietary ingredient is obtained from one or more suppliers identified in the petition. The regulation clarifies that we are willing to consider, on a case-bycase basis, a manufacturer’s conclusion, supported by appropriate data and information in the petition submission, that it has developed a system that it would implement as a sound, consistent means of establishing, with no material diminution of assurance compared to the assurance provided by 100 percent identity testing, the identity of the dietary ingredient before use. Section 111.75(a)(1) reflects our determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient. However, we recognize that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. To provide an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency, we added to § 111.75(a)(1), an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the Agency for such an exemption to 100 percent identity testing under 21 CFR 10.30 and the Agency grants such exemption. Such a procedure would be consistent with our stated goal, as described in the CGMP final rule, of providing flexibility in the CGMP requirements. Section E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68452-68453]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

Proposed Projects

    Title: ACF Program Instruction: Children's Justice Act.
    OMB No.: 0980-0196.
    Description: The Program Instruction, prepared in response to the 
enactment of the Childrens Justice Act (CJA), Title II of Public Law. 
111-320, Child Abuse Prevention and Treatment Act Reauthorization of 
2010, provides direction to the States and Territories to accomplish 
the purposes of assisting States in developing, establishing and 
operating programs designed to improve: (1) The assessment and 
investigation of suspected child abuse and neglect cases, including 
cases of suspected child sexual abuse and exploitation, in a manner 
that limits additional trauma to the child and the child's family; (2) 
the assessment and investigation of cases of suspected child abuse-
related fatalities and suspected child neglect-related fatalities; (3) 
the investigation and prosecution of cases of child abuse and neglect, 
including child sexual abuse and exploitation; and (4) the assessment 
and investigation of cases involving children with disabilities or 
serious health-related problems who are suspected victims of child 
abuse or neglect. This Program Instruction contains information 
collection requirements that are found in P. L. 111-320 at Sections 
107(b) and 107(d), and pursuant to receiving a grant award. The 
information being collected is required by statute to be submitted 
pursuant to receiving a grant award. The information submitted will be 
used by the agency to ensure compliance with the statute; to monitor, 
evaluate and measure grantee achievements in addressing the 
investigation and prosecution of child abuse and neglect; and to report 
to Congress.
    Respondents: State Governments

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Application & Annual Report.....................              52               1              60           3,120
                                                 ---------------------------------------------------------------
    Estimated total annual burden hours.........                                                           3,120
----------------------------------------------------------------------------------------------------------------

    In compliance with the requirements of Section 506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Planning, Research and Evaluation, 370 L'Enfant Promenade SW., 
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email 
address: infocollection@acf.hhs.gov. All requests should be identified 
by the title of the information collection.
    The Department specifically requests comments on: (a) Whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have 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

[[Page 68453]]

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.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013-27221 Filed 11-13-13; 8:45 am]
BILLING CODE 4184-01-P