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Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices6261reserve their heavy hand for conductthat falls within standards for per seillegality clearly enunciated by theSupreme Court. Accordingly, I cannotsupport the proposed enforcementaction made public today.[FR Doc. 97–3341 Filed 2–10–97; 8:45 am]BILLING CODE 6750–01–MDEPARTMENT OF HEALTH ANDHUMAN SERVICESCenters for Disease Control andPrevention[30DAY–28]Agency Forms Undergoing PaperworkReduction Act ReviewThe Centers for Disease Control andPrevention (CDC) publishes a list ofinformation collection requests underreview by the Office of Management andBudget (OMB) in compliance with thePaperwork Reduction Act (44 U.S.C.Chapter 35). To request a copy of theserequests, call the CDC Reports ClearanceOffice on (404) 639–7090. Send writtencomments to CDC, Desk Officer; HumanResources and Housing Branch, NewExecutive Office Building, Room 10235;Washington, DC 20503. Writtencomments should be received within 30days of this notice.The following request has beensubmitted for review since the lastpublication date on February 4, 1997.Proposed Project1. Biomechanical Stress Control inDrywall Installation—New-Drywallinstallers represented approximately1.42% of the construction workforce in1992. Based on analysis of theSupplementary Data System (BLS) of 21states, the compensable injury/incidence rate (27.5 cases per 100workers for this group) was nearly threetimes the injury rate of 9.5 for all otherconstruction occupations combined, in1987. Data from the 1992 and 1993Annual Survey of Occupational Injuriesand Illnesses (BLS) indicated that therewere an estimated 4,680 traumaticinjuries among drywall installersinvolving days away from work in theconstruction industry in 1992, and4,122 in 1993. In 1993, bodily reactionand exertion (31.8%), falls (28.6%), andcontact with objects (24.6%) were theleading events of injury and illnessinvolving days away from work. As aresult, sprains and strains (40.6%)constituted the most frequent nature ofinjuries and illnesses category in 1994.To gain an understanding of theseinjuries, NIOSH has initiated thisproject to examine different approachesin both field and laboratory settings toidentify and control the high-riskactivities associated with the traumaticinjuries and overexertion hazards ofdrywall installation work. One of thefield study components for this projectis to identify high-risk tasks andactivities for drywall installers, using adrywall installation survey which wasdeveloped at NIOSH. The findings ofthis survey will provide furtherunderstanding and focus laboratoryresearch efforts on the most hazardoustasks/activities of drywall-installationwork. Study populations will includedrywall installers or constructionworkers with drywall installationexperience. Each questionnaire will takeapproximately 20 minutes to complete.The total annual burden is 30.RespondentsNumber ofrespondentsNumber ofresponses/respondentAverageburden/response(in hrs.)Drywall Installers ...................................................................................................................................... 120 1 .25Dated: February 5, 1997.Wilma G. Johnson,Acting Associate Director for Policy Planningand Evaluation, Centers for Disease Controland Prevention (CDC).[FR Doc. 97–3332 Filed 2–10–97; 8:45 am]BILLING CODE 4163–18–PFood and Drug Administration[Docket No. 96E–0388]Determination of Regulatory ReviewPeriod for Purposes of PatentExtension; MERREM® I.V.AGENCY: Food and Drug Administration,HHS.ACTION: Notice.SUMMARY: The Food and DrugAdministration (FDA) has determinedthe regulatory review period forMERREM® I.V. and is publishing thisnotice of that determination as requiredby law. FDA has made thedetermination because of thesubmission of an application to theCommissioner of Patents andTrademarks, Department of Commerce,for the extension of a patent whichclaims that human drug product.ADDRESSES: Written comments andpetitions should be directed to theDockets Management Branch (HFA–305), Food and Drug Administration,12420 Parklawn Dr., rm. 1–23,Rockville, MD 20857.FOR FURTHER INFORMATION CONTACT:Brian J. Malkin, Office of Health Affairs(HFY–20), Food and DrugAdministration, 5600 Fishers Lane,Rockville, MD 20857, 301–443–1382.SUPPLEMENTARY INFORMATION: The DrugPrice Competition and Patent TermRestoration Act of 1984 (Pub. L. 98–417)and the Generic Animal Drug and PatentTerm Restoration Act (Pub. L. 100–670)generally provide that a patent may beextended for a period of up to 5 yearsso long as the patented item (humandrug product, animal drug product,medical device, food additive, or coloradditive) was subject to regulatoryreview by FDA before the item wasmarketed. Under these acts, a product’sregulatory review period forms the basisfor determining the amount of extensionan applicant may receive.A regulatory review period consists oftwo periods of time: A testing phase andan approval phase. For human drugproducts, the testing phase begins whenthe exemption to permit the clinicalinvestigations of the drug becomeseffective and runs until the approvalphase begins. The approval phase startswith the initial submission of anapplication to market the human drugproduct and continues until FDA grantspermission to market the drug product.Although only a portion of a regulatoryreview period may count toward theactual amount of extension that theCommissioner of Patents andTrademarks may award (for example,half the testing phase must besubtracted as well as any time that mayhave occurred before the patent wasissued), FDA’s determination of thelength of a regulatory review period fora human drug product will include allof the testing phase and approval phaseas specified in 35 U.S.C. 156(g)(1)(B).FDA recently approved for marketingthe human drug product MERREM® I.V.(meropenem). MERREM® I.V. isindicated as single agent therapy for thetreatment of the following infections