collection is approved subject to the following conditions: 1) FDA
should re-evaluate its efforts in response to the justification
questions on the use of information technology and consultation
outsid the agency, 2) FDA should undertake activities in both of
these areas to ensure adequate evaluation of the data collection
and its burden, and 3) FDA's next information collection request
should reflect changes as appropriate.
Inventory as of this Action
MANUFACTURERS OF HIV - TYPE OR II MUST
SUBMIT AN APPLICATION FOR APPROVAL BY THE FDA PRIOR TO MARKETING A
PRODUCT IN INTERSTATE COMMERCE. THE DATA IS USED BY THE AGENCY TO
DETERMINE THAT THE MANUFACTURER IS IN COMPLIANCE WITH THE LICENSING
PROVISIONS OF 21 CFR 601 PRIOR TO THE GRANTING OF A LICENSE TO
MARKET THE PRODUCT.