Agency Forms Undergoing Paperwork Reduction Act Review

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.

------------------------------------------------------------------------

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