Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Rules and Regulations 14669 

Issued in Washington, DC on March 23, 

2007. 

Rebecca MacPherson, 

Assistant Chief Counsel for Regulations. 

[FR Doc. 07–1524 Filed 3–28–07; 8:45 am] 

BILLING CODE 4910–13–M 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 402 

[Regulation No. 2; Docket No. SSA–2007–

0020] 

RIN 0960–AG46 

Technical Amendments To Correct 

Cross-References 

AGENCY: Social Security Administration. 

ACTION: Correcting amendments. 

SUMMARY: This document contains three 

technical corrections to our regulations. 

We are changing three cross-references 

because they are currently incorrect. 

EFFECTIVE DATE: Effective on March 29, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Rosemarie A. Greenwald, Social 

Insurance Specialist, Office of 

Regulations, Social Security 

Administration, 6401 Security 

Boulevard, Baltimore, MD 21235–6401. 

Call (410) 966–7813 or TTY 1–800–325–

0778 for information about these 

correcting amendments. For information 

on eligibility or filing for benefits, call 

our national toll-free numbers 1–(800)–

772–1213 or TTY 1–(800)–325–0778. 

You may also contact Social Security 

online at http:// 

www.socialsecurity.gov/. 

SUPPLEMENTARY INFORMATION: We are 

making corrections to our current 

regulations at 20 CFR 402.35(b)(2) 

which contain errors. The three crossreferences in the last sentence of 

§ 402.35(b)(2) incorrectly show 

§§ 404.984(b), 410.610c(b) and 

416.1484(b). We are changing these to 

reflect the correct cross-references. 

(Catalog of Federal Domestic Assistance 

Programs Nos. 96.001 Social Security—

Disability Insurance; 96.002 Social 

Security—Retirement Insurance; 96.004 

Social Security—Survivors Insurance and 

96.006 Supplemental Security Income. 

List of Subjects in 20 CFR Part 402 

Administrative practice and 

procedure; Freedom of information. 

Dated: March 21, 2007. 

Paul Kryglik, 

Acting SSA Regulations Officer. 

■ For the reasons set out in the 

preamble, part 402 of chapter III of title 

20 of the Code of Federal Regulations is 

corrected by making the following 

correcting amendments: 

PART 402—AVAILABILITY OF 

INFORMATION AND RECORDS TO 

THE PUBLIC 

■ 1. The authority citation for part 402 

continues to read as follows: 

Authority: Secs. 205, 702(a)(5), and 1106 of 

the Social Security Act; (42 U.S.C. 405, 

902(a)(5), and 1306); 5 U.S.C. 552 and 552a; 

8 U.S.C. 1360; 18 U.S.C. 1905; 26 U.S.C. 

6103; 30 U.S.C. 923(b); 31 U.S.C. 9701; E.O. 

12600, 52 FR 23781, 3 CFR, 1987 Comp., p. 

235. 

■ 2. Section 402.35 is corrected by 

revising the last sentence of paragraph 

(b)(2) to read as follows: 

§ 402.35 Publication. 

* * * * * 

(b) * * * 

(2) * * * For a description of Social 

Security Acquiescence Rulings, see 20 

CFR 404.985(c), 410.670c(b), and 

416.1485(c) of this title. 

* * * * * 

[FR Doc. E7–5494 Filed 3–28–07; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 201 and 310 

[Docket No. 1978N–0036L] (formerly Docket 

No. 1978N–036L) 

RIN 0910–AF38 

Laxative Drug Products for Over-theCounter Human Use; Psyllium 

Ingredients in Granular Dosage Forms 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

rule establishing that over-the-counter 

(OTC) laxative drug products in 

granular dosage form containing the 

bulk-forming psyllium ingredients 

(psyllium (hemicellulose), psyllium 

hydrophilic mucilloid, psyllium seed, 

psyllium seed (blond), psyllium seed 

husks, plantago ovata husks, and 

plantago seed) are not generally 

recognized as safe and effective 

(GRASE) and are misbranded. This final 

rule includes, but is not limited to, any 

granules that are swallowed dry prior to 

drinking liquid; dispersed, suspended, 

or partially dissolved in liquid prior to 

swallowing; chewed, partially chewed, 

or unchewed, and then washed down 

(or swallowed) with liquid; or sprinkled 

over food. FDA is issuing this final rule 

after considering reports of esophageal 

obstruction associated with the use of 

psyllium laxatives in granular dosage 

form. These cases continue to occur 

despite efforts to promote safe use 

through label warnings and directions. 

This final rule does not apply to 

psyllium laxatives in nongranular 

dosage forms, such as powders, tablets, 

or wafers. This final rule is part of 

FDA’s ongoing review of OTC drug 

products. 

DATES: Effective Date: This rule is 

effective October 1, 2007. 

Compliance Date: The compliance 

date for all products subject to this final 

rule, including products with annual 

sales less than $25,000, is October 1, 

2007. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Reynold Tan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, MS 5411, 

Silver Spring, MD 20993–0002, 301–

796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the advance notice of proposed 

rulemaking (ANPRM) for OTC laxative, 

antidiarrheal, emetic, and antiemetic 

drug products (40 FR 12902 at 12906, 

March 21, 1975), the advisory review 

panel on OTC laxative, antidiarrheal, 

emetic, and antiemetic drug products 

(the Panel) recommended Category I 

(GRASE and not misbranded) status for 

the OTC bulk laxative psyllium 

ingredients, which included plantago 

seed, plantago ovata husks, psyllium 

(hemicellulose), psyllium hydrophilic 

mucilloid, psyllium seed, psyllium seed 

(blond), and psyllium seed husks. FDA 

concurred with the Panel’s Category I 

classification of these ingredients in the 

tentative final monograph (TFM) 

published in the Federal Register of 

January 15, 1985 (50 FR 2124 at 2152). 

In the ANPRM, the Panel 

recommended a warning statement (21 

CFR 334.52(a)(1)) for bulk-forming 

laxatives that advised drinking a full 

glass, 8 ounces (oz), of liquid with each 


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