Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Notices 8023

Wilma G. Johnson, that insufficient data were available to to carbonless copy paper or its Acting Associate Director for Policy Planning conclude that the relationship between components. And Evaluation, Centers for Disease Control exposure to carbonless copy paper and 2. Epidemiology data assessing the and Prevention (CDC). the suggested health effects was a causal incidence of health effects associated [FR Doc. 97–4005 Filed 2–20–97; 8:45 am] one. with occupational exposure to BILLING CODE 4163±18±P Carbonless copy paper is used to carbonless copy paper. simultaneously make multiple paper 3. Medical case reports and studies of copies of an original document. This adverse health effects associated with National Institute for Occupational system eliminates the need for carbon occupational exposure to carbonless Safety and Health; Request for paper by using paper with a copy paper. These medical case reports Comments on the Toxicity of microencapsulated undercoating and studies should be submitted Carbonless Copy Paper containing dyes and solvents. Writing, without personal identifiers. AGENCY: National Institute for typing, or printing on the top sheet 4. Industrial hygiene data and reports Occupational Safety and Health breaks the microcapsules immediately from work places where carbonless copy (NIOSH), Centers for Disease Control underneath, releasing the dyes and paper is used or handled. and Prevention (CDC), Department of solvents to form the image on the paper 5. In Vivo or In Vitro toxicity data and Health and Human Services. surface below. Some substances used in studies on the components of carbonless ACTION: Request for comments. carbonless copy paper include aliphatic copy paper. compounds (C10–C14), aromatic All information received in response SUMMARY: NIOSH is requesting compounds such as alkyl substituted to this notice, except that designated as comments from all interested parties biphenyls (polychlorinated biphenyls trade secret and protected by section 15 concerning possible adverse health have not been used in carbonless copy of the Occupational Safety and Health effects among workers who have used paper in the United States since the Act, will be available for public carbonless copy paper. Interested early 1970’s), phenyl methyl benzenes examination and copying at the above parties may submit medical case and hydrogenated terphenyls, diaryl address. reports, experimental data, or other ethanes, alkyl benzenes, benzyl xylene, Dated: February 12, 1997. information relating to the effects isoparaffins, diisopropyl naththalenes, Linda Rosenstock, caused by such exposures. This dibutyl phthalate, glutaraldehyde, information will be used by NIOSH to Director, National Institute for Occupational formaldehyde, organic dyes, phenol- Safety and Health (NIOSH), Centers for evaluate whether exposure to the formaldehyde resin, kaolin, starch, Disease Control and Prevention (CDC). chemical substances in carbonless copy styrene, butadiene-latex, hydrogenated [FR Doc. 97–4280 Filed 2–20–97; 8:45 am] paper poses health risks, and to aluminum silicate, mineral oil, and BILLING CODE 4163±19±P determine the need for preventive sanatasol oil. health measures or additional research. Carbonless copy paper chemicals can DATES: Written comments to this notice be absorbed dermally or by inhalation. Availability of Draft Guidance on should be submitted to Diane Manning, Several factors such as chemical Childhood Lead Screening NIOSH Docket Office, 4676 Columbia composition and volume of the paper Parkway, M/S C–34, Cincinnati, Ohio used, ambient temperature and AGENCY: Centers for Disease Control and 45226 on or before April 22, 1997. ventilation rates in work or storage Prevention (CDC), Department of Health Comments may also be faxed to Diane areas, and work practices may affect the and Human Services. Manning at (513) 533–8285 or submitted extent of exposure. Adverse health ACTION: Notice of availability and by email to: [email protected] as effects in exposed workers were first request for comments. WordPerfect 5.0, 5.1/5.2, 6.0/6.1, or reported in the scientific literature in ASCII files. the late 1960’s. The signs and symptoms SUMMARY: This notice announces the FOR FURTHER INFORMATION CONTACT: attributed to dermal exposure have availability for review and comment of Technical information may be obtained included dryness, redness, irritation, a draft document entitled, ‘‘Screening from Dr. Paul A. Schulte, NIOSH, CDC, eczema, tingle, and itchiness of the skin. Young Children for Lead Poisoning.’’ 4676 Columbia Parkway, Mailstop C–14, The signs and symptoms attributed to The document was prepared by CDC Cincinnati, Ohio 45226, telephone (513) inhalation exposures have included staff with advice from CDC’s Advisory 533–8303. nasal congestion, drainage, bleeding, Committee on Childhood Lead SUPPLEMENTARY INFORMATION: Pursuant and irritation; upper respiratory tract Poisoning Prevention, a group of non- to sections 20 and 22 of the irritation; asthma; throat tickle and Federal experts on childhood lead Occupational Safety and Health Act of hoarseness; and joint pain, fatigue, and poisoning prevention. The document 1970 [29 U.S.C. 669 and 671], NIOSH is headache. also reflects the comments of many authorized to gather information in In order to update the information on other persons involved in scientific and order to develop recommendations for carbonless copy paper, NIOSH is programmatic aspects of childhood lead improving occupational safety and interested in obtaining existing and poisoning prevention and child health. health. NIOSH has been concerned available information published or DATES: To ensure consideration, written about reported undesirable health developed since 1987, including reports or verbal comments on this draft effects in workers occupationally and research findings, to evaluate document must be received by April 7, exposed to chemicals contained in or whether recommendations for health 1997. released from carbonless copy paper. On protection or further research on ADDRESSES: Requests for copies of the June 12, 1987, NIOSH published a carbonless copy paper chemicals are draft document must be made by calling Federal Register Notice (52 FR 22534) needed. Examples of requested the toll free telephone number: (888) requesting comments and secondary information include, but may not be 232–6789. Verbal comments on the draft data on the toxicity of carbonless copy limited to, the following: document may be made by calling the paper. At that time it was determined, 1. Adverse health signs or symptoms same toll free telephone number. based on the submitted information, associated with occupational exposure Written comments on the draft 8024 Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Notices document should be sent by mail or and pediatricians and other child SUPPLEMENTARY INFORMATION: In facsimile to: Nancy Tips, NCEH/CDC, health-care providers, public health compliance with section 3507 of the Mailstop F42, 4770 Buford Highway, agencies, and health care organizations, Paperwork Reduction Act of 1995 (44 N.E., Atlanta, GA, 30341–3724, including managed care organizations. U.S.C. 3507), FDA has submitted the facsimile (770) 488–7335. Dated: February 14, 1997. following proposed collection of SUPPLEMENTARY INFORMATION: Childhood Joseph R. Carter, information to OMB for review and lead poisoning is a major preventable clearance: Acting Associate Director for Management environmental health problem in the and Operations, Centers for Disease Control Medical Devices Standards Activities United States. Since 1975, when CDC and Prevention (CDC). Report (OMB Control Number 0910– issued its first comprehensive [FR Doc. 97–4281 Filed 2–20–97; 8:45 am] 0219—Extension) guidelines for preventing lead poisoning BILLING CODE 4163±18±P in children, ‘‘Increased Lead Absorption FDA is collecting information and Lead Poisoning in Young necessary to update a comprehensive Children,’’ CDC has worked with public Food and Drug Administration listing of current national and health agencies, child health-care international standards activities in the providers, and various concerned [Docket No. 97N±0025] field of medical devices. The collection groups to prevent lead poisoning in of this information is authorized by young children. Other editions of the Agency Information Collection section 514(a)(4)(B) of the Federal Food, guidelines have been published in 1975, Activities; Submission for OMB Drug, and Cosmetic Act (21 U.S.C. 1978, 1985, and 1991. Each revision has Review; Comment Request 360d(a)(4)(B)), which requires FDA to incorporated new scientific and consult with other nationally or AGENCY: Food and Drug Administration, practical information on how best to internationally recognized standard- HHS. reduce the adverse effects of lead on the setting entities, including other Federal health of young children. This draft ACTION: Notice. agencies concerned with standard- setting, in carrying out its responsibility guidance is narrower in scope than the SUMMARY: The Food and Drug 1991 edition of ‘‘Preventing Lead Administration (FDA) is announcing to establish special controls for medical Poisoning in Young Children.’’ It does that the proposed collection of devices. This report is used by not modify CDC’s position on adverse information listed below has been approximately 39 standards-developing health effects caused by lead. Instead, it submitted to the Office of Management organizations to coordinate their makes recommendations to improve the and Budget (OMB) for review and standards activities. This coordination use of screening to prevent lead clearance under the Paperwork prevents duplication of effort and poisoning among young children. These Reduction Act of 1995. insures efficient and expeditious recommendations are needed because management of standards development. data indicate that many children, DATES: Submit written comments on the Over 700 copies of this report are used especially those living in older housing, collection of information by March 24, by government, hospitals, libraries, continue to be heavily exposed to lead, 1997. industry, private citizens, and State and whereas the average exposure of ADDRESSES: Submit written comments local government agencies, including children in the United States has on the collection of information to the FDA, to keep abreast of standards substantially declined. To address this Office of Information and Regulatory development activities and current situation, the recommendations in this Affairs, OMB, New Executive Office technology concerning the safety of guidance are intended to increase the Bldg., 725 17th St. NW., rm. 10235, medical devices. Without the report, screening and follow-up care of children Washington, DC 20503, Attn: Desk there would be duplication of standards who most need these services and to Officer for FDA. efforts by voluntary standards ensure that prevention approaches are FOR FURTHER INFORMATION CONTACT: organizations because there is no other appropriate to local conditions. The Margaret R. Wolff, Office of Information publication that can be easily referenced audience for this guidance includes Resources Management (HFA–250), to ascertain if a certain medical device State and local public health officials, Food and Drug Administration, 5600 standard is being or has been developed. who will make screening Fishers Lane, rm. 16B–19, Rockville, FDA estimates the burden of this recommendations for their jurisdictions, MD 20857, 301–827–1223. collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN

Annual Frequency per No. of Respondents Response Total Annual Responses Hours per Response Total Hours

39 0.5 19.5 3 58.5 There are no capital costs or operating and maintenance costs associated with this collection of information.

This collection occurs biennially and Dated: February 12, 1997. [Docket No. 95D±0283] is voluntary. There are 39 national and William K. Hubbard, Deciding When to Submit a 510(k) for international organizations with one Associate Commissioner for Policy a Change to an Existing Device; report each reporting period. Coordination. Guidance; Availability [FR Doc. 97–4227 Filed 2–20–97; 8:45 am] BILLING CODE 4160±01±F AGENCY: Food and Drug Administration, HHS. ACTION: Notice.