[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Notices]
[Pages 48717-48718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23289]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


Agency Forms Undergoing Paperwork Reduction Act Review

    Periodically, the Public Health Service (PHS) publishes a list of 
information collection requests under review, in compliance with the 
Paperwork Reduction Act (44 U.S.C. 

[[Page 48718]]
Chapter 35). To request a copy of these requests, call the PHS Reports 
Clearance Office on (202)-690-5526.
    1. Tamper-Resistant Packaging Requirements for OTC Human Drug 
Products--0910-0149--Reinstatement, no change--This regulation requires 
certain OTC human drug and cosmetic products to be appropriately 
labeled, alerting customers to the tamper-resistant packaging. 
Respondents: Business or other for-profit; Number of Respondents: 500 
hours; Number of Responses per Respondent: 1; Average Burden per 
Response: 4 hours; Estimated Annual Burden: 2000 hours. Send comments 
to Allison Eydt, Human Resources and Housing Branch, New Executive 
Office Building, Room 10235, Washington, D.C. 20503.
    2. Anthelmintic Drug Products for OTC Human Use--0910-0232--
Reinstatement, no change--The existing rule provides conditions for the 
market of anthelmintic drug products for OTC use. One provision of the 
regulation requires the preparation and distribution of a consumer 
package insert related to the use of the drug by discussing pinworm 
infestation and its symptoms, identification, detection and treatment. 
Respondents: Business or other for-profit; Number of Respondents: 1; 
Number of Responses per Respondent: 1; Average Burden per Response: 24 
hours; Estimated Annual burden: 24 hours. Send comments to Allison 
Eydt, Human Resources and Housing Branch, New Executive Office 
Building, Room 10235, Washington, D.C. 20503.
    3. Aspartame as an Inactive Ingredient in Human Drug Products: 
Labeling Requirements--Reinstatement, no change--0910-0242--The final 
rule requires manufacturers of human drug products containing aspartame 
to declare on their product's label and labeling, a statement alerting 
phenylketonuries to the presence and amount of the component 
phenylalanine that is contained in the product per dosage unit. 
Respondents: Business or other for-profit. Number of Respondents: 50; 
Number of Responses per Respondent: 2; Average Burden per Response: .1 
hour; Estimated Annual burden: 10 hours. Send comments to Allison Eydt, 
Human Resources and Housing Branch, New Executive Office Building, Room 
10235, Washington, D.C. 20503.
    4. Foreign Language Disclosure Labeling--0910-0235--Reinstatement, 
no change--This label/labeling requirement is directed at manufacturers 
who wish to label their food products for foreign speaking consumers. 
Also, these provisions assure that the food is labeled with complete 
information in both English and the foreign language. Send comments to 
Allison Eydt, Human Resources and Housing Branch, New Executive Office 
Building, Room 10235, Washington, D.C. 20503.

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                                              Number of       Average   
                             Number of       responses/       burden/   
                            responsents      respondent       response  
------------------------------------------------------------------------
21 CFR 101.15(c)(2)--                600               1   1 hour.      
 Disclosure--Labeling.                                                  
21 CFR 101.15(c)(2)--                600               1   1 hour.      
 Disclosure--Labeling.                                                  
------------------------------------------------------------------------
Estimated Total Annual Burden: 1,200 hours.                             

    Written comments and recommendations concerning the proposed 
information collections should be sent by September 29 directly to the 
individual designated.

    Dated: September 15, 1995.
James Scanlon,
Director, Data Policy Staff, Office of the Assistant Secretary for 
Health and PHS Reports Clearance Officer.
[FR Doc. 95-23289 Filed 9-19-95; 8:45 am]
BILLING CODE 4160-01-M