[Federal Register Volume 59, Number 13 (Thursday, January 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1161]


[[Page Unknown]]

[Federal Register: January 20, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

21 CFR Ch. I

 [Docket No. 92N-0180]

 

Withdrawal of Certain Proposed Rules; Final Action

AGENCY: Food and Drug Administration, HHS.

ACTION: Withdrawal of proposed rules.

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SUMMARY: The Food and Drug and Administration (FDA) is announcing that 
it is withdrawing 9 of the 10 proposed rules that published in the 
notice of intent document that appeared in the Federal Register of 
January 19, 1993 (58 FR 4953). The nine proposed rules to be withdrawn 
include five proposals that were published before January 1, 1986, and 
four other proposed rules which were published on or after January 1, 
1986, but which are no longer considered viable candidates for final 
action. FDA is taking this action as part of its continuing 
comprehensive review of the agency's regulations process.

DATES: The proposed rules are withdrawn January 20, 1994.

FOR FURTHER INFORMATION CONTACT: Edwin V. Dutra, Jr., Office of Policy 
(HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-3480.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 28, 1991 
(56 FR 42668), FDA announced that it had begun a comprehensive review 
of the agency's regulations process, including a review of the backlog 
of advance notices of proposed rulemaking, notices of proposed 
rulemaking, and other notices for which no final rule or notice of 
withdrawal has been issued. The review was begun partly in response to 
criticism that the agency's backlog of pending proposals dilutes the 
agency's ability to concentrate its attention on higher priority 
regulations mandated by statute or necessary to protect public health. 
In the Federal Register of December 30, 1991 (56 FR 67440), FDA 
published a final action withdrawing 89 proposals.
     In the Federal Register of January 19, 1993 (58 FR 4953), FDA 
announced its intent to withdraw 10 proposed rules, 5 of which were 
published before January 1, 1986, but which were not withdrawn in the 
December 30, 1991, document and 5 other proposed rules which were 
published on or after January 1, 1986, but which are no longer 
considered viable candidates for final action.
     FDA received a total of 4 comments regarding the agency's notice 
of intent to withdraw the 10 documents (58 FR 4953). Three of the 
comments addressed the document on the proposed revocation of xylitol 
that published on October 20, 1971 (36 FR 20306). The comments 
supported the agency's efforts to withdraw the proposal.
     The fourth comment came from a drug manufacturer and disagreed 
with FDA's intention to withdraw the proposed amendments to the 
dissolution standard for erythromycin capsules that were published in 
the Federal Register of October 26, 1989 (54 FR 43592)). The October 
1989 document proposed to amend the current dissolution standard from 
``85 percent at 45 minutes'' to ``80 percent at 60 minutes'' in 21 CFR 
436.542(c) and 452.110c(b)(3). The manufacturer contends that in 
comparative studies the results indicated that the two products were 
bioequivalent despite the differences in dissolution.
     FDA agrees with this comment. The current United States 
Pharmacopeia (U.S.P.) dissolution standard requires ``80 percent 
dissolution in 60 minutes.'' The October 1989 proposal to revise the 
dissolution method from ``85 percent at 45 minutes'' to ``80 percent at 
60 minutes'' in 21 CFR 436.542(c) and 452.110c(b)(3) conforms with the 
current U.S.P. Data has been reviewed by the agency that would 
substantiate the claim that products from both the innovator firm and 
another manufacturer are bioequivalent in single as well as multiple 
dose studies. After further review of this matter, FDA has concluded 
that the current dissolution standard must be revised. Therefore, the 
agency is not withdrawing the proposed amendment for erythromycin 
capsules that was published on October 26, 1989 (54 FR 43592).
     Therefore, for the reasons set forth above, and under the Federal 
Food, Drug, and Cosmetic Act and the Public Health Service Act, the 
agency announces that it is withdrawing the following nine proposed 
rules, published in the Federal Register on the dates indicated:

------------------------------------------------------------------------
      Title and brief                                FR publication date
       description                Docket No.             and cite       
------------------------------------------------------------------------
 Infection in Chickens;      None................   Jan. 1, 1964, 29 FR 
 Proposed Nomenclature                              15                  
 Change; proposal to                                                    
 modify the poultry                                                     
 disease term ``chronic                                                 
 respiratory disease'' to                                               
 ``complicated chronic                                                  
 respiratory disease''.                                                 
 Xylitol; Proposed           89N-0421............   Oct. 20, 1971, 36 FR
 Revocation of Food                                 20306               
 Additive Regulation;                                                   
 revocation of unlimited                                                
 use of xylitol in special                                              
 dietary foods as codified                                              
 in 21 CFR 121.1114 (as                                                 
 recodified in 21 CFR                                                   
 172.395).                                                              
 Imminent Hazard Criteria    79N-0305............   Aug. 21, 1979, 44 FR
 and Procedure; Proposed                            48979               
 Rule; establishment of                                                 
 criteria and procedures                                                
 for determining whether                                                
 approval of certain human                                              
 and animal drugs should                                                
 be immediately suspended                                               
 under the ``imminent                                                   
 hazard'' provisions of                                                 
 the act1.                                                              
 Imminent Hazard             79N-0306............   Aug. 21, 1979, 44 FR
 Determinations;                                    48983               
 Separation of Functions;                                               
 Proposed Rule; rules to                                                
 govern the separation of                                               
 function in withdrawal                                                 
 proceedings involving                                                  
 products for which an                                                  
 imminent hazard has been                                               
 made and revocation of                                                 
 FDA criteria for making                                                
 recommendations to the                                                 
 Secretary concerning                                                   
 imminent hazard                                                        
 determinations.                                                        
 Export of Investigational   77N-0336............   Nov. 9, 1984, 49 FR 
 New Animal Drugs;                                  44766               
 Tentative Final Rule;                                                  
 provides for requirements                                              
 on notification and                                                    
 labeling investigational                                               
 animal drugs for export1.                                              
 Medical Devices;            83N-0190............   Jan. 6, 1986, 51 FR 
 Invitation for Offers to                           564                 
 Submit or to Develop a                                                 
 Performance Standard for                                               
 Vascular Graft Prosthesis                                              
 of 6 Millimeters and                                                   
 Greater Diameter; request                                              
 for any existing standard                                              
 as a proposed performance                                              
 standard for the vascular                                              
 graft prosthesis of 6                                                  
 millimeters and greater                                                
 diameter, or to submit an                                              
 offer to develop such a                                                
 proposed standard or the                                               
 agency will proceed to                                                 
 develop a performance                                                  
 standard.                                                              
 Medical Devices;            83N-0192............   Feb. 26, 1986, 51 FR
 Invitation for Offers to                           6862                
 Submit or to Develop a                                                 
 Performance Standard for                                               
 Central Nervous system                                                 
 Fluid Shunt and                                                        
 Components; request for                                                
 any existing standard as                                               
 a proposed performance                                                 
 standard for the central                                               
 nervous system fluid                                                   
 shunt and components, or                                               
 to submit an offer to                                                  
 develop such a proposed                                                
 standard or the agency                                                 
 will proceed to develop a                                              
 performance standard.                                                  
 Medical Devices;            85N-0030............  Apr. 3, 1986, 51 FR  
 Invitation for Offers to                           11516               
 Submit or Develop a                                                    
 Performance Standard for                                               
 Continuous Ventilator and                                              
 Ventilator Tubing;                                                     
 request for any existing                                               
 standard as a proposed                                                 
 performance standard for                                               
 the continuous ventilator                                              
 and for ventilator                                                     
 tubing, or to submit an                                                
 offer to develop such a                                                
 proposed standard or the                                               
 agency will proceed to                                                 
 develop a performance                                                  
 standard.                                                              
 Review of Investigational   86N-0072............   July 25, 1986, 51 FR
 Device Exemptions                                  26830               
 Regulations; Invitation                                                
 to Submit Comments, Data,                                              
 and Information; request                                               
 for information to assist                                              
 FDA in assessing the                                                   
 benefits, costs, and need                                              
 for revision of these                                                  
 regulations.                                                           
------------------------------------------------------------------------
\1\Signed by the Secretary of HHS.                                      



    Dated: Janauary 11, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-1161 Filed 1-19-94; 8:45 am]
BILLING CODE 4160-01-F