[Federal Register Volume 63, Number 58 (Thursday, March 26, 1998)]
[Rules and Regulations]
[Pages 14611-14612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7833]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 314 and 600
[Docket No. 93N-0181]
RIN 0910-AA97
Expedited Safety Reporting Requirements for Human Drug and
Biological Products; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a
document that appeared in the Federal Register of October 7, 1997 (62
FR 52237), to include some conforming amendments that were
inadvertently omitted. The final rule amended the expedited safety
reporting regulations for human drug and biological products. This
action is being taken to ensure the accuracy and consistency of the
regulations.
EFFECTIVE DATE: April 6, 1998.
FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-2994.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 7, 1997
(62 FR 52237), FDA amended, among other things, its regulations in
Sec. 314.80 Postmarketing reporting of adverse drug experiences (21 CFR
314.80) and Sec. 600.80 Postmarketing reporting of adverse experiences
(21 CFR 600.80). In that document, the agency inadvertently omitted
conforming amendments to Secs. 314.80(k) and 600.80(l) to correct the
current cross-references to Secs. 314.80(c)(1)(ii) and
600.80(c)(1)(ii). These paragraphs should reference
Secs. 314.80(c)(1)(iii) and 600.80(c)(1)(iii), respectively. This
correction does not, in any way, alter the scope or intent of the
October 7, 1997, document.
In final rule FR Doc. 97-26255, published on October 7, 1997 (62 FR
52237), make the following corrections:
Sec. 314.80 [Corrected]
1. On page 52251, in amendatory instruction 8, in the second
column, beginning in line 7, the phrase, ``; and by removing paragraph
(j) and redesignating paragraphs (k) and (l) as paragraphs (j) and (k),
respectively'' is corrected to read, ``; by removing paragraph (j),
redesignating paragraphs (k) and (l) as paragraphs (j) and (k),
respectively; and by revising the last sentence in newly redesignated
paragraph (k)''.
2. On page 52252, in the second column, in Sec. 314.80, the last
sentence of redesignated paragraph (k) is correctly revised to read as
follows:
Sec. 314.80 Postmarketing reporting of adverse drug experiences.
* * * * *
(k) * * * For purposes of this provision, the term ``applicant''
also includes any person reporting under paragraph (c)(1)(iii) of this
section.
Sec. 600.80 [Corrected]
3. On the page 52252, in the second column, in amendatory
instruction 10, beginning in line 5, the phrase, ``; and by removing
paragraph (j) and redesignating paragraphs (k), (l), and (m) as
paragraphs (j), (k), and (l),
[[Page 14612]]
respectively,'' is corrected to read, ``; by removing paragraph (j),
redesignating paragraphs (k), (l), and (m) as paragraphs (j), (k), and
(l), respectively; and by revising the last sentence in newly
redesignated paragraph (l)''.
4. On page 52253, in the second column, in Sec. 600.80, the last
sentence of newly redesignated paragraph (l) is correctly revised to
read as follows:
Sec. 600.80 Postmarketing reporting of adverse experiences.
* * * * *
(l) * * * For the purposes of this provision, this paragraph also
includes any person reporting under paragraph (c)(1)(iii) of this
section.
Dated: March 18, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7833 Filed 3-25-98; 8:45 am]
BILLING CODE 4160-01-F
