[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Notices]
[Pages 37923-37924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0260]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on voluntary customer/partner service surveys 
to implement Executive Order 12862.

DATES: Submit written comments on the collection of information by 
(insert date 60 days after date of publication in the Federal 
Register.)

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information 
Resources Management (HFA-80), Food and Drug Administration, 5600 
Fishers

[[Page 37924]]

Lane, rm. 16B-31, Rockville, MD 20857, 301-827-1471.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Customer/Partner Service Surveys

    Under section 903 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 393), FDA is authorized to conduct research relating to 
regulated articles and to conduct educational and public information 
programs relating to responsibilities of the agency. Executive Order 
12862, entitled ``Setting Customer Service Standards,'' directs Federal 
agencies that ``provide significant services directly to the public'' 
to ``survey customers to determine the kind and quality of services 
they want and their level of satisfaction with existing services.'' FDA 
is seeking OMB clearance to conduct a series of surveys and focus 
groups to implement Executive Order 12862. Participation in the surveys 
and focus groups will be voluntary. This request covers customer 
service surveys of regulated entities, such as food processors; 
cosmetic, drug, biologic and medical device manufacturers; consumers; 
and health professionals. The request also covers partner surveys of 
State and local governments.
    FDA will use the information gathered through surveys and focus 
groups to identify strengths and weaknesses in service to customers and 
partners and to make improvements. The surveys and focus groups will 
assess timeliness, appropriateness, accuracy of information, courtesy, 
and problem resolution in the context of individual programs.
    FDA projects 12 customer service and 12 partner service surveys per 
year, with a sample of between 500 and 2,000 customers each. After the 
first year, some of these surveys will be repeats of earlier surveys, 
for purposes of monitoring customer/partner service and developing 
long-term data. Also, FDA plans to conduct 12 focus groups per year (6 
for customers and 6 for partners), primarily for the purpose of gaining 
input into the design of service surveys.
    FDA estimates the burden of this collection of information as 
follows:


                    Estimated Annual Reporting Burden                   
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                              Annual                                    
 Type of      No. of       Frequency per     Hours per      Total Hours 
 Survey     Respondents      Response        Response                   
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Mail/                                                                   
 telepho                                                                
 ne                                                                     
 surveys   36,000               1                .25        9,000       
Focus                                                                   
 Groups       120               1               1.5           180       
Total      36,120               1                .255       9,180       
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There are no capital costs or operating and maintenance costs associated
  with this collection of information.                                  

    These estimates are based on experience with other surveys FDA has 
conducted.

    Dated: July 7, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-18525 Filed 7-14-97; 8:45 am]
BILLING CODE 4160-01-F