[Federal Register Volume 63, Number 55 (Monday, March 23, 1998)]
[Notices]
[Pages 13866-13867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Registration of 
Producers of Drugs and Listing of Drugs in Commercial Distribution; 
Submission for OMB Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
April 22, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

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:  In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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

    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 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

[[Page 13867]]

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 part 207.
     In the Federal Register of December 11, 1997 (62 FR 65274), the 
agency requested comments on the proposed collections of information. 
No significant comments were received.
    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.                                                                                                  

    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: March 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7476 Filed 3-20-98; 8:45 am]
BILLING CODE 4160-01-F