[Federal Register Volume 62, Number 238 (Thursday, December 11, 1997)]
[Notices]
[Pages 65274-65276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0486]


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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requirements governing the 
registration of producers of drugs and listing of drugs in commercial 
distribution.

DATES: Submit written comments on the collection of information by 
February 9, 1998.

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: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 
1320.39(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, including 
each proposed extension of an existing 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

[[Page 65275]]

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.

Registration of Producers of Drugs and Listing of Drugs in 
Commercial Distribution (21 CFR Part 207)--(OMB Control Number 
0910-0045--Extension)

    Under section 510 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360), FDA is authorized to establish a system for 
registration of producers of drugs and for listing of drugs in 
commercial distribution. To implement section 510 of the act, FDA 
issued part 207 (21 CFR part 207). The regulations require an initial 
listing of products and a twice-yearly update. In addition, all 
registered drug firms are required to re-register annually between 
January and July. The penalties for failure to register or drug list 
are potential seizure and injunctions, as well as criminal enforcement 
actions.
    The following are the specific reporting requirements under part 
207: (1) Section 207.20 requires that owners and operators of all drug 
establishments that engage in the manufacture, preparation, 
propagation, or processing of drugs must register and use Form FDA 2656 
(Registration of Drug Establishment) and Form FDA 2658 (Registered 
Establishments' Report of Private Label Distributors) to submit drug 
listing information or to request a Labeler Code, or both. (2) Section 
207.21 requires that owners and operators must register an 
establishment within 5 days of beginning operations and shall complete 
Form FDA 2656e (Annual Registration of Drug Establishment) each year 
between January and July. Annual registration forms are mailed by the 
FDA in each calendar year according to a schedule based on the 
establishment parent company's name and must be completed within 30 
days of the receipt. (3) Section 207.22(a) requires that Form FDA 2656 
must be submitted when an establishment registers the first time. An 
establishment whose drug registration is validated under Sec. 207.35(a) 
is required to make subsequent annual registrations as described in 
Sec. 207.21(a). (4) Section 207.22(b) requires that Form FDA 2657 must 
be submitted for the first listing of drugs and subsequent June and 
December updates. (5) Section 207.25 specifies the information required 
in the establishment registration and drug listing. (6) Section 
207.25(c) specifies the information about the drug that is required to 
be submitted (name, active ingredients, dosage strength, NDC number, 
manufacturer or distributor, size, shape, color, code imprint). (7) 
Section 207.26 specifies the information required in the amendments to 
the establishment registration. (8) Section 207.30 specifies the 
information required for updating the drug listing. (9) Section 207.31 
specifies additional drug listing information that may be needed beyond 
that required in Secs. 207.25 and 207.30.
    The information obtained from the establishment registration forms 
FDA 2656 and FDA 2656(e) is used by FDA and other government agencies 
to keep an accurate and current list of all human and animal drug 
manufacturers, repackers, relabelers and other drug processors located 
in this country. This list is used by FDA for inspectional purposes as 
required by the act. In addition, the data is used by the public and 
private sector as a listing of the names and locations of drug firms. 
The information obtained from the listing forms FDA-2657 and FDA-2658 
is used, through assignment of the National Drug Code numbers, for 
third party reimbursement payment in Medicare and Medicaid as well as 
other health care insurance firms.
    Respondents to this collection of information are all owners and 
operators that engage in the manufacture, preparation, propagation, 
compounding, or processing of drugs and that are not exempt under 
section 510(g) of the act or subpart D of 21 CFR 207.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      No. of                                                    
      Form        21 CFR Section      No. of       Responses per   Total Annual      Hours per      Total Hours 
                                    Respondents     Respondent       Responses       Response                   
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Form FDA-2656                                                                                                   
 Registration of                                                                                                
 Drug                                                                                                           
 Establishment        207.20                                                                                    
                      207.22                                                                                    
                      207.25                                                                                    
                      207.26        2,500               1           2,500                .5         1,250       
Form FDA-2656(e)                                                                                                
 Annual Re-                                                                                                     
 registration of                                                                                                
 Drug                                                                                                           
 Establishments       207.21                                                                                    
                      207.25                                                                                    
                      207.26        9,000               1           9,000                .5         4,500       
Form FDA-2657                                                                                                   
 Drug Product                                                                                                   
 Listing Form         207.22                                                                                    
                      207.30                                                                                    
                      207.31       45,000               1          45,000                .5        22,500       
 Form FDA-2658                                                                                                  
 Registered                                                                                                     
 Establishment's                                                                                                
 Report of                                                                                                      
 Private Label                                                                                                  
 Distribution         207.20                                                                                    
                      207.21                                                                                    
                      207.25                                                                                    
                      207.26        6,200               1           6,200                .5         3,100       
                      207.25(c)     1,500              12.04       18,066                .5         9,033       
Total                                                                                             40,383        
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


[[Page 65276]]

    These estimates are based on FDA's Center for Drug Evaluation and 
Research, Product Information Management Branch, and its data and 
information on drug listing and establishment registration of 
manufacturers, repackers, relabelers, and other drug processors.

    Dated: December 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32461 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F