Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Animal Feed Regulatory Program Standards; Availability, 41401-41403 [2013-16517]

Download as PDF 41401 Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 877–222–7570. Information requests can also be submitted by email to DCAS@CDC.GOV. John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2013–16550 Filed 7–9–13; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects: Title: Tribal Child Support Enforcement Direct Funding Request: 45 CFR 309–Plan. OMB No.: 0970–0218. Description: The final rule within 45 CFR part 309, published in the Federal Register on March 30, 2004, contains a regulatory reporting requirement that, in order to receive funding for a Tribal IV– D program a Tribe or Tribal organization must submit a plan describing how the Number of respondents Instrument Tribe or Tribal organization meets or plans to meet the objectives of section 455(f) of the Social Security Act, including establishing paternity, establishing, modifying, and enforcing support orders, and locating noncustodial parents. The plan is required for all Tribes requesting funding; however, once a Tribe has met the requirements to operate a comprehensive program, a new plan is not required annually unless a Tribe makes changes to its title IV–D program. Tribes and Tribal organizations must respond if they wish to operate a fully funded program. This paperwork collection activity is set to expire in September, 2013. Respondents: Tribes and Tribal Organizations. Number of responses per respondent Average burden hours per response Total burden hours 60 2 480 57,600. Estimated Total Annual Burden Hours ..................................................... TKELLEY on DSK3SPTVN1PROD with NOTICES 45 CFR 309–Plan ............................................................................................ ........................ ........................ ........................ 57,600. 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 of automated collection techniques or other forms of information technology. Consideration will be given to VerDate Mar<15>2010 17:42 Jul 09, 2013 Jkt 229001 comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. feed standards are neither final nor intended for implementation at this time. Submit either electronic or written comments on the collection of information by September 9, 2013. DATES: [FR Doc. 2013–16518 Filed 7–9–13; 8:45 am] BILLING CODE 4184–01–P Submit electronic comments on the collection of information to https:// 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. Submit written requests for single copies of the draft feed standards to the U.S. Food and Drug Administration, Office of Regulatory Affairs, Office of Partnerships, 12420 Parklawn Dr., ELEM–3033, Rockville, MD 20857. Send one self-addressed adhesive label to assist the office in processing your request, or fax your request to 301–827– 3588. See the SUPPLEMENTARY INFORMATION section for an electronic copy of the draft feed standards. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0764] Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Animal Feed Regulatory Program Standards; Availability 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with the draft Animal Feed Regulatory Program Standards (AFRPS). The draft SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: With regard to the information collection: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, E:\FR\FM\10JYN1.SGM 10JYN1 41402 Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices 301–796–7726, Ila.Mizachi@fda.hhs.gov. With regard to the draft feed program standards: Beverly Kent, Office of Partnerships, Food and Drug Administration, 716– 714–9503, Beverly.kent@fda.hhs.gov; or Jenny Murphy, Center for Veterinary Medicine, Food and Drug Administration, 240–453–6845, Jenny.murphy@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 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. TKELLEY on DSK3SPTVN1PROD with NOTICES Draft Animal Feed Regulatory Program Standards—(OMB Control Number 0910-New) I. Background In the United States, Federal and State government Agencies ensure the safety of animal feed. FDA is responsible for ensuring that all foods and feeds moving in interstate commerce, except those under the U.S. Department of VerDate Mar<15>2010 17:42 Jul 09, 2013 Jkt 229001 Agriculture jurisdiction, are safe, wholesome, and labeled properly. States are responsible for conducting inspections and regulatory activities that help ensure food and feed produced, processed, and distributed within their jurisdictions are safe and in compliance with State laws and regulations. States primarily perform inspections under their own regulatory authority. Some States conduct inspections of feed facilities under contract with FDA. Because jurisdictions may overlap, FDA and States collaborate and share resources to protect animal feed. The FDA Food Safety Modernization Act passed on January 4, 2011, calls for enhanced partnerships and provides a legal mandate for developing an Integrated Food Safety System (IFSS). FDA is committed to implementing an IFSS, thereby optimizing coordination of food and feed safety efforts with Federal, State, local, tribal, and territorial regulatory and public health agencies. Model standards provide a consistent, underlying foundation that is critical for uniformity across State and Federal Agencies to ensure credibility of food and feed programs within the IFSS. At this time, model regulatory program standards exist for human food, but do not exist for animal feed. The draft feed standards are a major step in a long-term process of collaboration to achieve uniformity and consistency in feed safety across the nation while acknowledging State responsibilities and authorities. II. Significance of Feed Program Standards The AFRPS provide a uniform and consistent approach to feed regulation in the United States. Implementation of the feed program standards would be voluntary. States implementing the standards will identify and maintain program improvements that will strengthen the safety and integrity of the U.S. animal feed supply. Description: These draft feed standards are the framework that each State should use to design, manage, and improve its feed program. Eleven standards describing regulatory foundation, training, inspection program, auditing, feed-related illness or death and emergency response, enforcement program, outreach activities, budget and planning, laboratory services, sampling program, and assessment and improvement of PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 standard implementation are the basis for the draft feed standards. Each standard has a purpose statement, requirement summary, description of program elements, projected outcomes, and a list of required documentation. When a State program voluntarily agrees to implement the draft feed standards, it must fully implement and maintain the individual program elements and documentation requirements in each standard in order to fully implement the standard. The State program must fully implement the 11 standards to achieve full implementation of the AFRPS. These program standards are not intended to address the performance appraisal processes that a State agency may use to evaluate individual employee performance. The standards have forms, worksheets, and templates to help the State program assess and meet the program elements in the standard. State programs are not obligated to use the forms, worksheets, and templates provided with the draft feed standards. Other manual or automated forms, worksheets, and templates may be used as long as the pertinent data elements are present. Records and other documents specified in the standards must be maintained in good order by the State program and must be available to verify the implementation of each standard. In the first year of implementation, the State program uses the selfassessment worksheets to determine if the requirements for each standard are fully met, partially met, or not met. The self assessments are used to develop an improvement plan for fully implementing the requirements of the 11 standards. Although FDA plans to provide financial support to State programs that implement the feed standards, funding opportunities are contingent upon the availability of funds. Funding opportunities may be only available to State feed regulatory programs that currently have an FDA feed inspection contract. State programs receiving financial support to implement the feed standards will be audited by FDA. III. Electronic Access Persons with access to the Internet may submit email requests for a single copy of the draft feed standards to OP– ORA@fda.hhs.gov. FDA estimates the burden of this collection of information as follows: E:\FR\FM\10JYN1.SGM 10JYN1 Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices 41403 TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 Respondent Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours State Feed Regulatory Programs in the United States ....... 50 1 50 3,000 150,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden has been calculated to 3,000 hours per respondent. The estimate includes time for reviewing the standards, gathering and maintaining the data and documents for each standard, and completing and reviewing the data and documents that would be spent to fully implement the 11 standards. FDA recognizes that full use and implementation of the feed standards by State feed programs will occur over many years and the number of years to fully implement the feed standards will vary among States. This burden was determined by averaging the burden estimates received from five respondents. The five respondents are representative of the State feed programs in the United States. Dated: July 3, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–16517 Filed 7–9–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0797] Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation 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 information collection requirements relating to FDA regulations for human tissue intended for transplantation. TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:42 Jul 09, 2013 Jkt 229001 Submit either electronic or written comments on the collection of information by September 9, 2013. ADDRESSES: Submit electronic comments on the collection of information to https:// 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: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 7726, Ila.Mizrachi@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 DATES: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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. Human Tissue Intended for Transplantation—21 CFR Part 1270 (OMB Control Number 0910–0302)— Extension Under section 361 of the Public Health Services (PHS) Act (42 U.S.C. 264), FDA issued regulations under part 1270 (21 CFR part 1270) to prevent the transmission of human immunodeficiency virus, hepatitis B, and hepatitis C, through the use of human tissue for transplantation. The regulations provide for inspection by FDA of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of human tissue. These facilities are required to meet provisions intended to ensure appropriate screening and testing of human tissue donors and to ensure that records are kept documenting that the appropriate screening and testing have been completed. Sections 1270.31(a) through (d) require written procedures to be prepared and followed for the following steps: (1) All significant steps in the infectious disease testing process under § 1270.21; (2) all significant steps for obtaining, reviewing, and assessing the relevant medical records of the donor as prescribed in § 1270.21; (3) designating and identifying quarantined tissue; and (4) for prevention of infectious disease contamination or cross-contamination by tissue during processing. Sections 1270.31(a) and (b) also requires recording and justification of any deviation from the written procedures. Section 1270.33(a) requires records to be maintained concurrently with the performance of each significant step required in the performance of infectious disease screening and testing of human tissue donors. Section 1270.33(f) requires records to be retained regarding the determination of the suitability of the donors and of the records required under § 1270.21. Section 1270.33(h) requires all records E:\FR\FM\10JYN1.SGM 10JYN1

Agencies

[Federal Register Volume 78, Number 132 (Wednesday, July 10, 2013)]
[Notices]
[Pages 41401-41403]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16517]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0764]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Draft Animal Feed Regulatory Program Standards; 
Availability

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection associated with 
the draft Animal Feed Regulatory Program Standards (AFRPS). The draft 
feed standards are neither final nor intended for implementation at 
this time.

DATES: Submit either electronic or written comments on the collection 
of information by September 9, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to https://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. Submit 
written requests for single copies of the draft feed standards to the 
U.S. Food and Drug Administration, Office of Regulatory Affairs, Office 
of Partnerships, 12420 Parklawn Dr., ELEM-3033, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist the office in 
processing your request, or fax your request to 301-827-3588. See the 
SUPPLEMENTARY INFORMATION section for an electronic copy of the draft 
feed standards.

FOR FURTHER INFORMATION CONTACT: With regard to the information 
collection:

Ila S. Mizrachi, Office of Information Management, Food and Drug 
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,

[[Page 41402]]

301-796-7726, Ila.Mizachi@fda.hhs.gov.
    With regard to the draft feed program standards:
Beverly Kent, Office of Partnerships, Food and Drug Administration, 
716-714-9503, Beverly.kent@fda.hhs.gov; or
Jenny Murphy, Center for Veterinary Medicine, Food and Drug 
Administration, 240-453-6845, Jenny.murphy@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 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.

Draft Animal Feed Regulatory Program Standards--(OMB Control Number 
0910-New)

I. Background

    In the United States, Federal and State government Agencies ensure 
the safety of animal feed. FDA is responsible for ensuring that all 
foods and feeds moving in interstate commerce, except those under the 
U.S. Department of Agriculture jurisdiction, are safe, wholesome, and 
labeled properly. States are responsible for conducting inspections and 
regulatory activities that help ensure food and feed produced, 
processed, and distributed within their jurisdictions are safe and in 
compliance with State laws and regulations. States primarily perform 
inspections under their own regulatory authority. Some States conduct 
inspections of feed facilities under contract with FDA. Because 
jurisdictions may overlap, FDA and States collaborate and share 
resources to protect animal feed.
    The FDA Food Safety Modernization Act passed on January 4, 2011, 
calls for enhanced partnerships and provides a legal mandate for 
developing an Integrated Food Safety System (IFSS). FDA is committed to 
implementing an IFSS, thereby optimizing coordination of food and feed 
safety efforts with Federal, State, local, tribal, and territorial 
regulatory and public health agencies. Model standards provide a 
consistent, underlying foundation that is critical for uniformity 
across State and Federal Agencies to ensure credibility of food and 
feed programs within the IFSS.
    At this time, model regulatory program standards exist for human 
food, but do not exist for animal feed. The draft feed standards are a 
major step in a long-term process of collaboration to achieve 
uniformity and consistency in feed safety across the nation while 
acknowledging State responsibilities and authorities.

II. Significance of Feed Program Standards

    The AFRPS provide a uniform and consistent approach to feed 
regulation in the United States. Implementation of the feed program 
standards would be voluntary. States implementing the standards will 
identify and maintain program improvements that will strengthen the 
safety and integrity of the U.S. animal feed supply.
    Description: These draft feed standards are the framework that each 
State should use to design, manage, and improve its feed program. 
Eleven standards describing regulatory foundation, training, inspection 
program, auditing, feed-related illness or death and emergency 
response, enforcement program, outreach activities, budget and 
planning, laboratory services, sampling program, and assessment and 
improvement of standard implementation are the basis for the draft feed 
standards.
    Each standard has a purpose statement, requirement summary, 
description of program elements, projected outcomes, and a list of 
required documentation. When a State program voluntarily agrees to 
implement the draft feed standards, it must fully implement and 
maintain the individual program elements and documentation requirements 
in each standard in order to fully implement the standard. The State 
program must fully implement the 11 standards to achieve full 
implementation of the AFRPS. These program standards are not intended 
to address the performance appraisal processes that a State agency may 
use to evaluate individual employee performance.
    The standards have forms, worksheets, and templates to help the 
State program assess and meet the program elements in the standard. 
State programs are not obligated to use the forms, worksheets, and 
templates provided with the draft feed standards. Other manual or 
automated forms, worksheets, and templates may be used as long as the 
pertinent data elements are present. Records and other documents 
specified in the standards must be maintained in good order by the 
State program and must be available to verify the implementation of 
each standard.
    In the first year of implementation, the State program uses the 
self-assessment worksheets to determine if the requirements for each 
standard are fully met, partially met, or not met. The self assessments 
are used to develop an improvement plan for fully implementing the 
requirements of the 11 standards.
    Although FDA plans to provide financial support to State programs 
that implement the feed standards, funding opportunities are contingent 
upon the availability of funds. Funding opportunities may be only 
available to State feed regulatory programs that currently have an FDA 
feed inspection contract. State programs receiving financial support to 
implement the feed standards will be audited by FDA.

III. Electronic Access

    Persons with access to the Internet may submit email requests for a 
single copy of the draft feed standards to OP-ORA@fda.hhs.gov.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 41403]]



                                                    Table 1--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                             Respondent                                 Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Feed Regulatory Programs in the United States................              50                1               50            3,000          150,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden has been calculated to 3,000 hours per respondent. The 
estimate includes time for reviewing the standards, gathering and 
maintaining the data and documents for each standard, and completing 
and reviewing the data and documents that would be spent to fully 
implement the 11 standards. FDA recognizes that full use and 
implementation of the feed standards by State feed programs will occur 
over many years and the number of years to fully implement the feed 
standards will vary among States. This burden was determined by 
averaging the burden estimates received from five respondents. The five 
respondents are representative of the State feed programs in the United 
States.

    Dated: July 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16517 Filed 7-9-13; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.