WASHINGTON _ The FDA's Center for Biologics Evaluation andResearch (CBER) has extended the time frame for public commentson its review of the federal regulations governing biologictherapeutic products. CBER will now accept comments until Feb. 13,1995. In addition, the agency will hold a public meeting on the topicsometime in the next few months.
Launched last June, CBER's internal review of biologics regulationscontained in title 21 of the Code of Federal Regulations (21 CFR),parts 600, 601 and 610, is to make "the process [of biologic productreview and licensure] work more smoothly and efficiently forindustry and for the agency," according to CBER consumer safetyofficer Timothy Beth. "We're asking for comments on any aspect ofthe regulations."
In a new twist on its traditional rule-making procedures, the FDA isseeking public comments on 21 CFR before it issues any proposedrule changes as a result of its own internal review. "It's hopefullygoing to save time, energy and money to get industry comments nowinstead of after a proposed rule is published," Beth told BioWorld.So far, CBER has received 12 public comments on 21 CFR.However, Beth said a number of those comments came fromindustry associations representing several hundred companies.
Beth said that the FDA's current review of 21 CFR will likely resultin changes to the regulations. Any proposed changes would undergofurther public comment before final regulations were published.
The FDA has extended the public comment period twice now and, inresponse to requests from the Biotechnology Industry Organizationand the Pharmaceutical Research and Manufacturers of America,plans to hold a public meeting to gather more public comments on21 CFR. Beth said the meeting will likely be scheduled in lateDecember or early January 1995.
For further information on FDA review of 21 CFR and proceduresfor public comment submissions, contact Timothy Beth at CBER'sOffice of Compliance: (301) 594-3074. Notice of the publiccomment period extension and planned public meeting waspublished on Nov. 14, 1994 in the Federal Register, pages 56448-56449.
NIH Publishes Guidelines For Research Agreements
The National Institutes of Health (NIH) has finalized a Points toConsider document for academic and non-profit institutions thatreceive federal funding for research and then enter into industrycollaborations. The document covers so-called "sponsored researchagreements," the interactions between NIH grant recipients andindustry.
The new guidelines are the result of a review of 375 sponsoredresearch agreements negotiated by NIH grantees. That review wascarried out under the aegis of the NIH Task Force onCommercialization of Intellectual Property Rights from NIH-Supported Extramural Research.
Points for consideration covered in the document include academicfreedom, dissemination of research results, development andcommercialization of NIH-funded technology, U.S. manufacturing requirements, and invention,license and patent notification requirements.
The full text of the NIH guidelines appeared in the Federal Registeron Nov. 8, 1994, pp. 55673-55678. For more information, contactTheodore Roumel, Assistant to the deputy director for science policyand technology transfer: (301) 496-7057.
BIO Trade Mission Blazes Trails Through China
A delegation of Biotechnology Industry Organization (BIO)companies has spent the last eight days in the People's Republic ofChina on a "trailblazing mission," according to BIO president CarlFeldbaum. For the next two days, the group will be in Tokyo.
Feldbaum, speaking from Tokyo, told BioWorld on Tuesday that theChina portion of BIO's Asian trade mission was focused on threegoals: identifying promising research and researchers, gauging thecapabilities of investigators and institutions for conducting clinicaltrials and evaluating pharmaceutical manufacturing facilities.
"Due to the population, there's an enormous sample size availablefor studying many different diseases in the Peoples Republic ofChina," said Feldbaum. "For example, there's 100 million peopleinfected with hepatitis B here. In addition, there's an enormous lungcancer problem due to smoking and bad air." High concentrations ofindividuals with specific diseases could speed patient accrual inclinical trials, Feldbaum pointed out.
Although BIO's initial visit was focused on therapeutic drugs,Chinese officials and researchers repeatedly expressed an interest inagricultural technologies. "The Chinese are probably as interested infood and agriculture as they are in pharmaceutical development,"said Feldbaum. "With a 1.2 billion population, they are interested inany biotechnology techniques that could increase crop yields or thenutritional content of foods, as well as confer insect or viralresistance to foods."
During the Tokyo leg of BIO's trade mission, 21 emergingbiotechnology companies will present their technologies to 49Japanese companies and one Taiwanese company that are looking toinvest. "The bad news is that the U.S. markets have been so tight,these companies have been driven off-shore for investors," saidFeldbaum. "The good news is that the Japanese are interested ininvesting in some of these technologies."n
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.