Title 21

PART 316 SUBPART B

Subpart B - Written Recommendations for Investigations of Orphan Drugs

• 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
• 57 FR 62085, Dec. 29, 1992, unless otherwise noted.

21:5.0.1.1.6.2.1.1	SECTION 316.10	316.10 Content and format of a request for written recommendations.
21:5.0.1.1.6.2.1.2	SECTION 316.12	316.12 Providing written recommendations.
21:5.0.1.1.6.2.1.3	SECTION 316.14	316.14 Refusal to provide written recommendations.

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