52138 Federal Register / Vol. 62, No. 193 / Monday, October 6, 1997 / Notices withdrawn from sale for reasons of DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: safety or effectiveness (§ 314.162 (21 HUMAN SERVICES Mehul U. Mehta, Center for Drug CFR 314.162)). Evaluation and Research (HFD–860), Food and Drug Administration FDA regulations provide that any Food and Drug Administration, 5600 person may petition the agency for a Fishers Lane, Rockville, MD 20857, 301–594–0501. determination as to whether a listed [Docket No. 97D±0410] SUPPLEMENTARY INFORMATION: FDA is drug has been voluntarily withdrawn Guidance for Industry on SUPAC±MR, from sale for reasons of safety announcing the availability of a Modified Release Solid Oral Dosage guidance for industry entitled ‘‘SUPAC– effectiveness (§ 314.161(b) (21 CFR Forms; Scale-Up and Postapproval 314.161(b))). Richard A. Hamer MR: Modified Release Solid Oral Dosage Changes for Chemistry, Forms; Scale-Up and Postapproval submitted a citizen petition dated May Manufacturing, and Controls; Changes: Chemistry, Manufacturing, 24, 1996, under 21 CFR 10.25(a), 10.30, Availability and Controls; In Vitro Dissolution and 314.122(a), requesting that the Testing and In Vivo Bioequivalence AGENCY: agency determine whether Food and Drug Administration, Documentation.’’ The purpose of this chlorhexidine gluconate topical tincture HHS. guidance document is to provide insight  0.5% (Hibitane ) was withdrawn from ACTION: Notice. and recommendations to sale for reasons of safety or pharmaceutical sponsors of NDA’s, SUMMARY: effectiveness. Zeneca Pharmaceuticals The Food and Drug ANDA’s, and AADA’s who intend to (formerly Steuart Pharmaceuticals and Administration (FDA) is announcing the change: (1) The components or ICI Americas) obtained approval of NDA availability of a guidance for industry composition; (2) the manufacturing 18–049 for chlorhexidine gluconate entitled ‘‘SUPAC–MR: Modified Release (process or equipment); (3) the scale-up/ topical tincture 0.5% on December 18, Solid Oral Dosage Forms; Scale-Up and scale-down of manufacture; and/or (4) 1978, as a patient preoperative skin Postapproval Changes: Chemistry, the site of manufacture of a modified preparation. The product was Manufacturing, and Controls; In Vitro release solid oral formulation during the Dissolution Testing and In Vivo withdrawn from sale by the sponsor in postapproval period. The guidance Bioequivalence Documentation.’’ The early 1984. Because the sponsor document defines the following: (1) purpose of this guidance document is to discontinued marketing of the product, Levels of change; (2) recommended provide insight and recommendations to chemistry, manufacturing, and controls the agency currently lists chlorhexidine pharmaceutical sponsors of new drug gluconate topical tincture 0.5% in the (CMC) tests to support each level of applications (NDA’s), abbreviated new change; (3) recommended in vitro Orange Book’s ‘‘Discontinued Drug drug applications (ANDA’s), and Product List.’’ dissolution release tests and/or in vivo abbreviated antibiotic applications bioequivalence tests to support each FDA has reviewed its records and, (AADA’s) who intend to change the level of change; and (4) documentation under §§ 314.161 and 314.162(a)(2), has components or composition, the to support the change. determined that chlorhexidine manufacturing (process or equipment), For postapproval changes for gluconate topical tincture 0.5% was the scale-up/scale-down of manufacture, modified release dosage forms that withdrawn from sale for reasons of and/or the site of manufacture of a affect components and composition, safety. Specifically, the product was modified release solid oral formulation manufacturing process or equipment withdrawn because of the significant during the postapproval period. This changes, scale-up, and site change, this number of reports received concerning guidance document represents the guidance supersedes the chemical and thermal burns associated agency’s current thinking on scale-up recommendations in section 4.G of the with the use of the product. Therefore, and postapproval changes (SUPAC) for Office of Generic Drugs Policy and chlorhexidine gluconate topical tincture modified release solid oral dosage forms Procedure Guide 22–90 (FDA, regulated by the Center for Drug 0.5% will be removed from the list of September 11, 1990). For all other Evaluation and Research (CDER). drug products with effective approvals dosage forms and changes, this guidance published in FDA’s publication, DATES: Written comments may be does not affect the recommendations in ‘‘Approved Drug Products with submitted at any time. Guide 22–90. Therapeutic Equivalence Evaluations.’’ ADDRESSES: Submit written requests for This guidance document represents FDA will not accept ANDA’s that refer single copies of ‘‘SUPAC–MR: Modified the agency’s current thinking on SUPAC to this drug product. Release Solid Oral Dosage Forms; Scale- for modified release solid oral dosage Up and Postapproval Changes: forms regulated by CDER. It does not Dated: September 26, 1997. Chemistry, Manufacturing, and create or confer any rights for or on any William K. Hubbard, Controls; In Vitro Dissolution Testing person and does not operate to bind Associate Commissioner for Policy and In Vivo Bioequivalence FDA or the public. An alternative Coordination. Documentation’’ to the Drug approach may be used if such approach [FR Doc. 97–26353 Filed 10–3–97; 8:45 am] Information Branch (HFD–210), Center satisfies the requirements of the BILLING CODE 4160±01±F for Drug Evaluation and Research, Food applicable statute, regulations, or both. and Drug Administration, 5600 Fishers Interested persons may, at any time, Lane, Rockville, MD 20857. Send two submit written comments on the self-addressed adhesive labels to assist guidance document to the Dockets that office in processing your requests. Management Branch (address above). Submit written comments on the Two copies of any comments are to be guidance document to the Dockets submitted, except that individuals may Management Branch (HFA–305), Food submit one copy. Comments are to be and Drug Administration, 12420 identified with the docket number Parklawn Dr., rm. 1–23, Rockville, MD found in brackets in the heading of this 20857. document. A copy of the guidance Federal Register / Vol. 62, No. 193 / Monday, October 6, 1997 / Notices 52139 document and received comments may Health Services (CMHS) was established disorders, which are excluded, unless be seen in the office above between 9 within SAMHSA to coordinate Federal they co-occur with another diagnosable a.m. and 4 p.m., Monday through efforts in the prevention, treatment, and serious emotional disturbance’’ (p. Friday. promotion of mental health. Title II of 29425). An electronic version of this guidance Public Law 102–321 establishes a Block Further, the definition indicates that, is also available on the Internet at http:/ Grant for Community Mental Health ‘‘Functional impairment is defined as /www.fda.gov/cder/guidance/ Services (Block Grant) administered by difficulties that substantially interfere index.htm. CMHS, which permits the allocation of with or limit a child or adolescent from Dated: September 29, 1997. funds to States for the provision of achieving or maintaining one or more William K. Hubbard, community mental health services to developmentally-appropriate social, Associate Commissioner for Policy children with a serious emotional behavioral, cognitive, communicative, Coordination. disturbance and adults with a serious or adaptive skills. Functional [FR Doc. 97–26412 Filed 10–3–97; 8:45 am] mental illness. Public Law 102–321 impairments of episodic, recurrent, and BILLING CODE 4160±01±F stipulates that States estimate the continuous duration are included unless incidence (number of new cases) and they are temporary and expected prevalence (total number of cases in a responses to stressful events in their DEPARTMENT OF HEALTH AND year) in their applications for Block environment. Children who would have HUMAN SERVICES Grant funds, see 42 U.S.C. 300 (2). The met functional impairment criteria statute also requires the Secretary to during the referenced year without the Substance Abuse and Mental Health establish definitions for adults with a benefit of treatment or other support Services Administration serious mental illness and children with services are included in this definition’’ a serious emotional disturbance. In (p. 29425). Estimation Methodology for Children addition, the Secretary is required to The first decision that was made was With a Serious Emotional Disturbance develop standardized methods for the to focus on community epidemiological (SED) states to use in providing the estimates studies done in the United States that AGENCY: Center for Mental Health required as part of their block grant used either the DSM–III–R, or its Services, Substance Abuse and Mental applications. See 42 U.S.C. 300 (2). As predecessor, the DSM–III, and that Health Services Administration, HHS. part of the process of implementing this provided information on the prevalence new block grant, definitions of the terms ACTION: Solicitation of comments. of mental disorders using a structured ‘‘children with a serious emotional interview procedure. The group decided SUMMARY: This notice describes the disturbance’’ and ‘‘adults with a serious that given the relatively small number of proposed methodology for identifying mental illness’’ were announced on May community epidemiological studies that and estimating the number of children 20, 1993, in Federal Register Volume had been conducted in the United with a serious emotional disturbance 58, No 96, p. 29422. Subsequently, a States, it would be a mistake to exclude (SED) within each State. This notice is group of technical experts was those few studies that had used the being served as part of the requirement convened by CMHS to develop an DSM–III, given its considerable of Public Law 102–321, the ADAMHA estimation methodology to similarity to the DSM–III–R. Reorganization Act of 1992. ‘‘operationalize the key concepts’’ in the The most frequently used structured COMMENT PERIOD: The Administrator is definition of children with a serious interview procedure was the Diagnostic requesting written comments which emotional disturbance. A similar group Interview Schedule for Children (DISC), must be received on or before December has prepared an estimation originally developed by A. Costello and 5, 1997. methodology for adults with a serious his colleagues (A. Costello, Edelbrock, ADDRESSES: Comments should be sent to mental illness. Dulcan, Kalas, & Klaric, l984), which Judith Katz-Leavy, M.Ed., Senior Policy Serious Emotional Disturbance (SED) includes both child and parent versions. Analyst, Office of Policy, Planning, and Other interview procedures include the Administration, Center for Mental The CMHS definition is that Diagnostic Interview for Children and Health Services, Parklawn Building ‘‘children with serious emotional Adolescents (DICA, Herjanic & Reich, Room 15–87, 5600 Fishers Lane, disturbance’’ are persons: l982), the Child and Adolescent Rockville, MD 20857. (301) 443–1563 —From birth up to age 18; Psychiatric Assessment (CAPA, Angold fax. —Who currently or at any time during & E. Costello, l995), and the Composite FOR FURTHER INFORMATION CONTACT: A the past year; International Diagnostic Interview (CIDI, detailed paper outlining the estimation —Have had a diagnosable mental, Kessler et al, 1994). methodology described here is available behavioral, or emotional disorder of The group elected to consider that a from: Judith Katz-Leavy M.Ed., Senior sufficient duration to meet diagnostic child met the criteria of a diagnosable Policy Analyst, Office of Policy, criteria specified within DSM–III–R disorder either if a diagnosis was Planning, and Administration, Center —That resulted in functional obtained from his/her own report on the for Mental Health Services, Parklawn impairment which substantially structured interview, or from the Building Room 15–87, 5600 Fishers interferes with or limits the child’s parent’s report on the structured Lane, Rockville, MD 20857. (301)443– role or functioning in family, school, interview, or from the combination of 1563 fax. or community activities (p.29425). the youth’s report and the parent’s The definition goes on to indicate report, even if neither one met the Background that, ‘‘these disorders include any criteria separately. While there are other Public Law 102–321, the ADAMHA mental disorder (including those of approaches to combining data from two Reorganization Act of 1992, amended biological etiology) listed in DSM–III–R or more sources that were considered the Public Health Service Act and or their ICD–9–CM equivalent (and and have been used (Cohen, Velez, & created the Substance Abuse and Mental subsequent revisions) with the Kohn, l987; Reich & Earls, 1987), the Health Services Administration exception of DSM–III–R ‘V’ codes, group chose to use this ‘‘either/or’’ (SAMHSA). The Center for Mental substance use, and developmental approach because it was believed that