81 FR 89947 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 239 (December 13, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 239 (December 13, 2016)
| Page Range | 89947-89949 | |
| FR Document | 2016-29839 |
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)] [Notices] [Pages 89947-89949] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29839] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0764] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) 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. DATES: Fax written comments on the collection of information by January 12, 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: [[Page 89948]] 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0760. Also include the FDA 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Animal Feed Regulatory Program Standards--OMB 0910-0760--Extension I. Background In the United States, Federal and State Government Agencies ensure the safety of animal feed. FDA is responsible for ensuring that all food and feed 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. II. Significance of Feed Program Standards The Animal Feed Regulatory Program Standards (AFRPS) provide a uniform and consistent approach to feed regulation in the United States. Implementation of the draft feed program standards is 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. The feed standards are the framework that each State should use to design, manage, and improve its feed program. The standards include the following: (1) Regulatory foundation; (2) training; (3) inspection program; (4) auditing; (5) feed-related illness or death and emergency response; (6) enforcement program; (7) outreach activities; (8) budget and planning; (9) assessment and improvement; (10) laboratory services; and (11) sampling program. 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 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 feed standards package includes 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 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 feed standards must be maintained in good order by the State program and must be available to verify the implementation of each standard. The feed standards are not intended to address the performance appraisal processes that a State Agency may use to evaluate individual employee performance. 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. Second and third-year assessments will provide progress evaluation. 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 requests for a single copy of the current feed standards from [email protected]. Please note that due to editorial revisions and public comments, the final standards may differ from the copy you receive. In the Federal Register of April 12, 2016 (81 FR 21578), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment. However, this comment did not address the information collection. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- State Employee..................................................... 40 1 40 3,000 120,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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. This burden was determined by capturing the average amount of time for each respondent to assess the current state of the program and work toward implementation of each of the 11 standards contained in AFRPS. 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 [[Page 89949]] fully implement the feed standards will vary among States. Dated: December 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29839 Filed 12-12-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices 89947
information marked as ‘‘confidential’’ period for a human biological product In its application for patent extension,
will not be disclosed except in will include all of the testing phase and this applicant seeks 5 years of patent
accordance with 21 CFR 10.20 and other approval phase as specified in 35 U.S.C. term extension.
applicable disclosure law. For more 156(g)(1)(B).
FDA has approved for marketing the III. Petitions
information about FDA’s posting of
comments to public dockets, see 80 FR human biologic product NUCALA Anyone with knowledge that any of
56469, September 18, 2015, or access (mepolizumab). NUCALA is indicated the dates as published are incorrect may
the information at: http://www.fda.gov/ for add-on maintenance treatment of submit either electronic or written
regulatoryinformation/dockets/ patients with severe asthma aged 12 comments and ask for a redetermination
default.htm. years and older, and with an (see DATES). Furthermore, any interested
Docket: For access to the docket to eosinophilic phenotype. Subsequent to person may petition FDA for a
read background documents or the this approval, the USPTO received a determination regarding whether the
electronic and written/paper comments patent term restoration application for applicant for extension acted with due
received, go to https:// NUCALA (U.S. Patent No. 5,693,323) diligence during the regulatory review
www.regulations.gov and insert the from GlaxoSmithKline LLC, and the period. To meet its burden, the petition
docket number, found in brackets in the USPTO requested FDA’s assistance in must be timely (see DATES) and contain
heading of this document, into the determining this patent’s eligibility for sufficient facts to merit an FDA
‘‘Search’’ box and follow the prompts patent term restoration. In a letter dated investigation. (See H. Rept. 857, part 1,
and/or go to the Division of Dockets May 10, 2016, FDA advised the USPTO 98th Cong., 2d sess., pp. 41–42, 1984.)
Management, 5630 Fishers Lane, Rm. that this human biological product had Petitions should be in the format
1061, Rockville, MD 20852. undergone a regulatory review period specified in 21 CFR 10.30.
FOR FURTHER INFORMATION CONTACT:
and that the approval of NUCALA Submit petitions electronically to
Beverly Friedman, Office of Regulatory represented the first permitted https://www.regulations.gov at Docket
Policy, Food and Drug Administration, commercial marketing or use of the No. FDA–2013–S–0610. Submit written
10903 New Hampshire Ave., Bldg. 51, product. Thereafter, the USPTO petitions (two copies are required) to the
Rm. 6250, Silver Spring, MD 20993, requested that FDA determine the Division of Dockets Management (HFA–
301–796–3600. product’s regulatory review period. 305), Food and Drug Administration,
II. Determination of Regulatory Review 5630 Fishers Lane, Rm. 1061, Rockville,
SUPPLEMENTARY INFORMATION:
Period MD 20852.
I. Background Dated: December 8, 2016.
FDA has determined that the
The Drug Price Competition and applicable regulatory review period for Leslie Kux,
Patent Term Restoration Act of 1984 NUCALA is 6,862 days. Of this time, Associate Commissioner for Policy.
(Pub. L. 98–417) and the Generic 6,496 days occurred during the testing [FR Doc. 2016–29838 Filed 12–12–16; 8:45 am]
Animal Drug and Patent Term phase of the regulatory review period, BILLING CODE 4164–01–P
Restoration Act (Pub. L. 100–670) while 366 days occurred during the
generally provide that a patent may be approval phase. These periods of time
extended for a period of up to 5 years were derived from the following dates: DEPARTMENT OF HEALTH AND
so long as the patented item (human 1. The date an exemption under HUMAN SERVICES
drug product, animal drug product, section 505(i) of the Federal Food, Drug,
medical device, food additive, or color and Cosmetic Act (21 U.S.C. 355(i)) Food and Drug Administration
additive) was subject to regulatory became effective: January 22, 1997. The [Docket No. FDA–2013–N–0764]
review by FDA before the item was applicant claims January 21, 1997, as
marketed. Under these acts, a product’s the date the investigational new drug Agency Information Collection
regulatory review period forms the basis application (IND) became effective. Activities; Submission for Office of
for determining the amount of extension However, FDA records indicate that the Management and Budget Review;
an applicant may receive. IND effective date was January 22, 1997, Comment Request; Animal Feed
A regulatory review period consists of which was 30 days after FDA receipt of Regulatory Program Standards
two periods of time: A testing phase and the IND.
an approval phase. For human 2. The date the application was AGENCY: Food and Drug Administration,
biological products, the testing phase initially submitted with respect to the HHS.
begins when the exemption to permit human biological product under section ACTION: Notice.
the clinical investigations of the 351 of the Public Health Service Act (42
biological product becomes effective SUMMARY: The Food and Drug
U.S.C. 262): November 4, 2014. FDA has
and runs until the approval phase Administration (FDA) is announcing
verified the applicant’s claim that the
begins. The approval phase starts with that a proposed collection of
biologics license application (BLA) for
the initial submission of an application information has been submitted to the
NUCALA (BLA 125526) was initially
to market the human biological product Office of Management and Budget
submitted on November 4, 2014.
and continues until FDA grants 3. The date the application was (OMB) for review and clearance under
permission to market the biological approved: November 4, 2015. FDA has the Paperwork Reduction Act of 1995.
product. Although only a portion of a verified the applicant’s claim that BLA DATES: Fax written comments on the
collection of information by January 12,
pmangrum on DSK3GDR082PROD with NOTICES
regulatory review period may count 125526 was approved on November 4,
toward the actual amount of extension 2015. 2017.
that the Director of the USPTO may This determination of the regulatory ADDRESSES: To ensure that comments on
award (for example, half the testing review period establishes the maximum the information collection are received,
phase must be subtracted as well as any potential length of a patent extension. OMB recommends that written
time that may have occurred before the However, the USPTO applies several comments be faxed to the Office of
patent was issued), FDA’s determination statutory limitations in its calculations Information and Regulatory Affairs,
of the length of a regulatory review of the actual period for patent extension. OMB, Attn: FDA Desk Officer, FAX:
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![Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices 89949
fully implement the feed standards will collection of information to OMB for ComplianceRegulatoryInformation/
vary among States. review and clearance. Guidances/Blood/UCM446580.pdf) that
Dated: December 8, 2016. Donor Risk Assessment Questionnaire changed the blood donor criterion for
for FDA/National Heart, Lung, and men who have sex with men (MSM)
Leslie Kux,
Blood Institute (NHLBI)-sponsored from an indefinite (permanent) deferral
Associate Commissioner for Policy.
Transfusion-Transmissible Infections to a 12-month deferral since last MSM
[FR Doc. 2016–29839 Filed 12–12–16; 8:45 am] Monitoring System (TTIMS)—Risk contact. The impact of this change in
BILLING CODE 4164–01–P Factor Elicitation OMB Control the deferral criteria requires a national
Number—New monitoring effort as part of TTIMS to
FDA intends to interview blood assess if the relative proportions of risk
DEPARTMENT OF HEALTH AND donors to collect risk factor information factors for infection in blood donors
HUMAN SERVICES associated with testing positive for a have changed following the adoption of
Transfusion-Transmissible Infection the 12-month donor deferral for MSM.
Food and Drug Administration
(TTI). This collection of information is TTIMS will use similar procedures as
[Docket No. FDA–2016–N–2836] part of a larger initiative called TTIMS, the ones used in the REDS–II study to
which is a collaborative project funded monitor and evaluate risk factors among
Agency Information Collection by FDA, the NHLBI of the National HIV-positive donors and recently HCV
Activities; Submission for Office of Institutes of Health (NIH), and the or HBV infected donors as well as
Management and Budget Review; Department of Health and Human controls.
Comment Request; Donor Risk Services (HHS) Office of the Assistant This study will help identify the
Assessment Questionnaire for the Secretary of Health with input from specific risk factors for TTI and their
Food and Drug Administration/National other Agencies in HHS, including the prevalence in blood donors, and help
Heart, Lung, and Blood Institute- Centers for Disease Control and inform FDA on the proportion of
Sponsored Transfusion-Transmissible Prevention (CDC). FDA will use these incident (new) infections among all HIV
Infections Monitoring System—Risk scientific data collected through such positive blood donors. Donations with
Factor Elicitation interview-based risk factor elicitation of incident infections have the greatest
AGENCY: Food and Drug Administration, blood donors to monitor and help potential transmission risk because they
HHS. ensure the safety of the U.S. blood could be missed during routine blood
supply. screening. The study will help FDA
ACTION: Notice. Previous assessments of risk factor evaluate the effectiveness of screening
SUMMARY: The Food and Drug profiles among blood donors found to be strategies in reducing the risk of HIV
Administration (FDA) is announcing positive for human immunodeficiency transmission from at-risk donors and to
that a proposed collection of virus (HIV) were funded by CDC for evaluate if there are unexpected
information has been submitted to the approximately 10 years after consequences associated with the recent
Office of Management and Budget implementation of HIV serologic change in donor deferral policy such as
(OMB) for review and clearance under screening of blood donors in the mid- an increase in HIV incidence among
the Paperwork Reduction Act of 1995. 1980s; whereas studies of Hepatitis C donors. These data also will inform FDA
DATES: Fax written comments on the
virus (HCV) seropositive donors, funded regarding future blood donor deferral
collection of information by January 12, by NIH, were conducted in the early policy options to reduce the risk of HIV
2017. 1990s. Information on current risk transmission, including the feasibility of
factors in blood donors as assessed moving from the existing time-based
ADDRESSES: To ensure that comments on
using analytical study designs was next deferrals related to risk behaviors to
the information collection are received, evaluated by the Transfusion- alternate deferral options, such as the
OMB recommends that written Transmitted Retrovirus and Hepatitis use of individual risk assessments, and
comments be faxed to the Office of Virus Rates and Risk Factors Study to inform the design of potential studies
Information and Regulatory Affairs, conducted by the NHLBI Retrovirus to evaluate the feasibility and
OMB, Attn: FDA Desk Officer, FAX: Epidemiology Donor Study-II (REDS–II) effectiveness of such alternative deferral
202–395–7285, or emailed to oira_ approved under OMB control number options.
submission@omb.eop.gov. All 0925–0630. Through a risk factor TTIMS will include a comprehensive
comments should be identified with the questionnaire, this study elicited risk interview based epidemiological study
OMB control number 0910—New and factors in blood donors who tested of risk factor information for viral
title ‘‘Donor Risk Assessment confirmed positive for one of four infection-positive blood donors at the
Questionnaire for the Food and Drug transfusion-transmissible infections: American Red Cross (ARC), Blood
Administration/National Heart, Lung, HIV, HCV, Hepatitis B virus (HBV), and Systems, Inc. (BSI), New York Blood
and Blood Institute-sponsored Human T-cell Lymphotropic virus. The Center (NYBC), and OneBlood that will
Transfusion-Transmissible Infections study also elicited risk factors from identify the current predominant risk
Monitoring System—Risk Factor donors who did not have any infections factors and reasons for virus-positive
Elicitation.’’ Also include the FDA (controls) and compared their responses donations. The TTIMS program
docket number found in brackets in the to those of the donors with confirmed establishes a new, ongoing donor
heading of this document. infection (cases). Results from the hemovigilance capacity that currently
FOR FURTHER INFORMATION CONTACT: FDA REDS–II study were published in 2015. does not exist in the United States.
pmangrum on DSK3GDR082PROD with NOTICES
PRA Staff, Office of Operations, Food FDA issued a document entitled Using procedures developed by the
and Drug Administration, Three White ‘‘Revised Recommendations for REDS–II study, TTIMS will establish
Flint North, 10A63, 11601 Landsdown Reducing the Risk of Human this capacity in greater than 50 percent
St., North Bethesda, MD 20852, Immunodeficiency Virus Transmission of all blood donations collected in the
PRAStaff@fda.hhs.gov. by Blood and Blood Products, Guidance country.
SUPPLEMENTARY INFORMATION: In for Industry’’ dated December 2015 As part of the TTIMS project, a
compliance with 44 U.S.C. 3507, FDA (http://www.fda.gov/downloads/ comprehensive hemovigilance database
has submitted the following proposed BiologicsBloodVaccines/Guidance will be created that integrates the risk
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Document Created: 2016-12-13 02:44:52
Document Modified: 2016-12-13 02:44:52
| 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 January 12, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 89947 |
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