The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

On November 13, 2018, the U.S. Environmental Protection Agency (EPA) announced the submission for review of an information collection request (ICR) on the Renewable Fuel Standard (RFS) Program to the Office of Management and Budget (OMB).  83 Fed. Reg. 56319.  The Federal Register notice states that purpose of this submission is to obtain OMB approval of an ICR that consolidates some existing collections.  By consolidating the existing collections and recordkeeping updates, EPA is aiming to create a new, consistent, and easily understandable format to report burden and cost estimates related to the RFS program.  Additionally, the ICR requests approval of updates to the recordkeeping and reporting burden along with cost estimated in December 2017.  EPA requested comments on this ICR for a 60-day period.  The November 13, 2018, notice extends the request for public comments by an additional 30 days.  Additional comments may be submitted on or before December 13, 2018.  The estimated burden approximates 566,665 hours per year, with a total estimated cost of $57,457,330 per year.  The cost estimate includes $0 of annualized capital or operation and maintenance costs.

Tags: EPA, RFS, OMB, Biofuel

 

By Lynn L. Bergeson

On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act through the addition of Section 351(k). The BPCI Act also amended the Federal Food, Drug, and Cosmetic Act to include Section 351(k) under human drug applications for prescription drug user fees provisions. The Program is meant to “create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. This allows a company to apply for licensure of a biosimilar or interchangeable biological product.” In 2012, the Biosimilar User Fee Act (BsUFA) allowed FDA to assess and collect user fees for activities connected with biosimilar biological product development (BPD). Some of these activities include the submission and review of forms, as well as an annual survey of all BsUFA participants.
 
The information collection proposal estimates an annual reporting burden of 57 hours, based on the number of respondents, the number of responses per respondent, the total annual responses, and the average burden per response. OMB will be accepting comments on FDA’s collection of information proposal until December 5, 2018.

Tags: FDA, OMB

 

By Lynn L. Bergeson

On May 11, 2018, the U.S. Environmental Protection Agency (EPA) sent a proposed renewable fuel standard (RFS) biofuel volumes rule for 2019 to the White House Office of Management and Budget (OMB) for pre-publication review.  The proposed rule addresses 2019 renewable blending obligations for cellulosic biofuel, advanced biofuel, and total biofuel, with a proposed 2020 percentage standard for biomass-based diesel. The 2019 blending requirement for biomass-based diesel is 2.1 billion gallons and was included in a final rule from 2017.

Tags: EPA, RFS, OMB

 

By Lynn L. Bergeson

On March 12, 2018, the U.S. Department of Agriculture (USDA) issued in the Federal Register a notice announcing the submission of an information collection request (ICR) on the guidelines for designating biobased products for federal procurement to the Office of Management and Budget (OMB). Pursuant to Section 9002 of the Farm Security and Rural Investment Act (FSRIA) of 2002, as amended by the Food, Conservation, and Energy Act (FCEA) of 2008, and the Agricultural Act of 2014, federal agencies are required to purchase biobased products under the preferred procurement program.  Product categories for preferred procurement are established by rulemaking based on the availability of biobased products, the economic and technological feasibility of using such products, and the costs of using such products.  Additionally, federal agencies are provided with information on the availability, price, performance, and environmental and public health benefits of such product categories, and, where appropriate, the recommended level of biobased material to be contained in the procured product.  Such information is gathered under the ICR from biobased product manufacturers and vendors by the Office of Procurement and Property Management (OPPM) and its contractors.  USDA is seeking comments on:

  • Whether the collection of information is necessary for the proper performance of the functions of USDA, including whether the information will have practical utility;
  • The accuracy of USDA’s estimate of burden, including the validity of the methodology and assumptions used;
  • Ways to enhance the quality, utility, and clarity of the information to be collected; and
  • Ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Tags: USDA, OMB, Comments

 

By Kathleen M. Roberts

On April 25, 2017, the U.S. Department of Agriculture’s (USDA) Rural Business-Cooperative Service published in the Federal Register a notice that it is requesting approval from the Office of Management and Budget (OMB) of a revision to a currently approved information collection for the Advanced Biofuel Payment Program, which provides funding to eligible advanced biofuel producers to support the production of biofuel products.  The Rural Business-Cooperative Service is specifically seeking comments on the following topics:

  • Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
  • The accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used;
  • Ways to enhance the quality, utility, and clarity of the information to be collected; and
  • Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.                          
Comments on this notice, which are due by June 26, 2017, will be summarized and included in the request for OMB approval. 

 

On August 22, 2014, the U.S. Environmental Protection Agency (EPA) sent the final 2014 Renewable Fuel Standard (RFS) rule to the Office of Management and Budget (OMB) for its review and formal publication in the Federal Register. This much anticipated review is the last step before public release. Nearly nine months behind schedule currently, it is unclear whether OMB will move quickly to release and publish the rule. Typically, OMB can take anywhere between 30 to 90 days to review a proposal, or significantly longer as has been the case with more controversial rules sent from EPA. As EPA received 340,000 comments on its proposed rulemaking, a speedy review seems unlikely. Current speculation suggests modest increases, at best, are expected from OMB review and that the rule will be issued in final shortly after, or possibly before, the mid-term elections in November.

More information is available online. The current status of the 2014 RFS rulemaking at the OMB is available online.

The Biobased and Renewable Products Advocacy Group (BRAG®) recently published a report describing EPA's actions delaying the final 2014 RFS rule, and the impact of the continuing delays on the RFS debate. A copy of that report is available online.

Tags: biofuels, RFS, OMB