[Federal Register Volume 61, Number 212 (Thursday, October 31, 1996)]
[Notices]
[Pages 56240-56242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0287]


Agency Information Collection Activities; 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.

DATES: Submit written comments on the collection of information by 
December 2, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the

[[Page 56241]]

Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC, Attn: Desk Officer 
for FDA.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collection of information to OMB for review and 
clearance:

Investigational New Drug Application (IND) Regulations (21 CFR Part 
312) (OMB Control Number 0910-0014)

    FDA has the responsibility under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) to issue 
regulations under which the clinical investigation of the safety and 
effectiveness of unapproved new drugs can be conducted. The IND 
information requirements are needed to ensure the safe and ethical 
investigation of the safety and effectiveness of new drugs.
    FDA is charged with implementing statutory requirements that drug 
products marketed in the United States be shown to be safe and 
effective and be properly manufactured and properly labeled for their 
intended uses. The act provides in section 505(a) that a new drug may 
not be introduced or delivered for introduction into interstate 
commerce in the United States unless FDA has previously approved a new 
drug application (NDA). FDA approves an NDA only if the sponsor of the 
application first demonstrates that the drug is safe and effective for 
the conditions prescribed, recommended, or suggested in the product's 
labeling. Proof must consist, in part, of adequate and well-controlled 
studies, including studies in humans, that are conducted by qualified 
experts.
    The IND regulations establish reporting requirements that include 
an initial application as well as amendments to that application, 
reports on significant revisions of clinical investigation plans, and 
information on a drug's safety or effectiveness. In addition, the 
sponsor is required to give FDA an annual summary of the previous 
year's clinical experience. Submissions are reviewed by medical 
officers and other agency scientific reviewers assigned responsibility 
for overseeing the specific study.
    The IND regulations also contain recordkeeping requirements that 
pertain to the responsibilities of sponsors and investigators. The 
detail and complexity of these requirements is dictated by the 
scientific procedures and human subject safeguards which must be 
followed in the clinical tests of investigational new drugs.
    FDA estimates the burden of the information collection provisions 
of the IND regulations as follows:




[[Page 56242]]



                                        Estimated Annual Reporting Burden                                       
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                                               Annual                                                           
    21 CFR Section           No. of        Frequency per      Total Annual        Hours per        Total Hours  
                          Respondents         Response         Responses          Response                      
----------------------------------------------------------------------------------------------------------------
312.7................          7                1                  7          24 hours               168        
312.10...............         12                1                 12           5 hours                60        
312.23...............      1,623                1              1,623          100 hours          162,300        
312.30...............      1,201                9             10,809          84 hours           907,956        
312.31...............        880                5.64           4,963           8 hours            39,704        
312.32...............        440                8              3,520          20 hours            70,400        
312.33...............      1,517                2.6            3,944          450 hours         1,774,800       
312.35...............          5                1                  5          260 hours            1,300        
312.36...............        300                1                300           5 hours             1,500        
312.38...............        579                1.2              695          45 minutes             521        
312.44...............        300                1                300          16 hours             4,800        
312.45...............        205                1.4              287           5 hours             1,435        
312.47...............        100                1                100          24 hours             2,400        
312.53...............      4,000                1              4,000          84 hours           336,000        
312.55...............        500                1                500          16 hours             8,000        
312.56...............        560                2.4            1,344          84 hours           112,896        
312.58...............        260                2.6              676          84 hours            56,784        
312.64...............      1,500                1.3            2,000          24 hours            48,000        
312.66...............        700                1                700           8 hours             5,600        
312.83...............          5                1                  5          160 hours              800        
312.85...............        260                2.6              676          960 hours          648,960        
312.110..............         30               11.6              348          24 hours             8,352        
312.120(b)...........        560                2.4            1,344          100 hours          134,000        
312.120(c)(3)........        560                2.4            1,344           3 hours             4,032        
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There are no capital costs or operating and maintenance costs associated with this information collection.      


                                      Estimated Annual Recordkeeping Burden                                     
----------------------------------------------------------------------------------------------------------------
                           No. of         Annual Frequency    Total Annual        Hours per                     
   21 CFR Section       Recordkeepers    per Recordkeeping       Records        Recordkeeper       Total Hours  
----------------------------------------------------------------------------------------------------------------
312.52.............        280                  1                280          30 minutes             140        
312.57.............        560                  2.4            1,344          100 hours          134,400        
312.59.............        250                  2.4              600           8 hours             4,800        
312.62(a)..........      4,000                  1              4,000          40 hours           160,000        
312.62(b)..........      4,000                 10             40,000          40 hours          1,600,000       
312.160(a).........        250                 40             10,000          30 minutes           5,000        
312.160(c).........        250                 30              7,500          30 minutes           3,750        
Total Burden Hours.                                                                             6,238,858       
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There are no capital costs or operating and maintenance costs associated with this information collection.      


    Dated: October 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 96-27993 Filed 10-30-96; 8:45 am]
BILLING CODE 4160-01-F