[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]
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