Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 43

DECLARATION of Amy A. Barcelo in Support re: 40 MOTION for Summary Judgment.. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M)(Barcelo, Amy)

§ 5.82

Title 21-Food and Drugs

chapter, except those pertaining to urokinase products and ingredients packaged together with containers intended
for the collection, processing, or storage
of blood and blood components for which
tuthority has been delegated in paragraph (b) of this section.
(b) The Director, Deputy Director,
and Associate Director of the Bureau of
Biologics are authorized to perform all
the functions of the Commissioner of
Food and Drugs with regard to the approval of new drug applications and supplements thereto which are for drugs for
human use pertaining to urokinase products and ingredients packaged together
with containers intended for the collection, processing, or storage of blood or
blood components and which have been
submitted pursuant to section 505 of the
Federal Food, Drug, and Cosmetic Act.
§ 5.82 Issuance of notices relating to
proposals to refuse approval or to
withdraw approval of new-drug applications and their supplements.
.(a) The Director and Deputy Director
of the Bureau of Drugs are authorized
to issue notices of an opportunity for a
hearing on proposals to refuse approval
or to withdraw approval of new drug applications and abbreviated new drug
applications and supplements thereto
which are for drugs for human use and
have been submitted pursuant to section
505 of the Federal Food, Drugs, and Cosmetic Act and §§ 314.1 and 314.8 of this
chapter, except those pertaining to
urokinase products and ingredients
packaged together with containers intended for the collection, processing, or
storage of blood and blood components
for which authority has been delegated
in paragraph (b) of this section, and to
issue notices of withdrawal of approval
when opportunity for hearing has been
waived.
(b) The Director, Deputy Director, and
Associate Director of the Bureau of
Biologics are authorized to issue notices
of opportunity for hearing on proposals
to refuse approval or to withdraw approval of new drug applications and abbreviated new drug applications and supplements thereto which are for drugs for
human use pertaining to urokinase products and ingredients packaged together
with containe-s intended for the collection, processing, or storage of blood or
blood components and which have been
submitted pursuant to section 505 of the

Federal Food, Drug, and Cosmetic Act
and §§ 314.1 and 314.8 of this chapter,
and to issue notices of withdrawal of approval when opportunity for hearing has
been waived.
§ 5.83 Approval of new animal drug
applications and their supplements.
The Director of the Bureau of Veterinary Medicine is authorized to perform
all the functions of the Commissioner
of Food and Drugs with regard to the
approval of new animal drug applications, and supplements thereto, for new
animal drugs submitted pursuant to section 512 of the Federal Food, Drug, and
Cosmetic Act. The Director of the Division of Animal Feeds of the Bureau of
Veterinary Medicine is authorized to
perform tfhe functions of the Commissioner with regard to the approval of
applications for animal feeds containing
new animal drugs.
§ 5.84 Issuance of notices relating to
proposals to refuse approval or to
withdraw approval of new animal
drug applications and their supplements.
The Director of the Bureau of Veterinary Medicine is authorized to issue notices of an opportunity for a hearing on
proposals to refuse approval or to withdraw approval of new animal drug applications and new animal drug application
supplements for drugs for animal use
submitted pursuant to section 512 of the
Federal Food, Drug, and Cosmetic Act
and to issue notices of withdrawal of
approval when opportunity for hearing
has been waived.
§ 5.86 Granting and withdrawing variances from performance standards
for electronic products.
The Director and Deputy Director of
the Bureau of Radiological Health are
authorized to grant and withdraw variances from the provisions of performance standards for electronic products
established in Subchapter J of this chapter.
§ 5.87 Exemptions from performance
standards for electronic products.
The Director of the Bureau of Radiological Health is authorized to exempt
from performance standards any electronic product intended solely or predominantly for departments or agencies
of the United States under section 358
(a) (5) of the Public Health Service Act.