Food and Drug Administration, HHS.
Final rule; technical amendments.
The Food and Drug Administration (FDA) is making technical amendments to its regulations that address food labeling, common or usual names for nonstandardized foods, infant formulas, food standards, and dietary supplements. The purpose of the amendments is to update the names, addresses, and phone numbers for FDA offices and professional organizations, to correct minor errors and inadvertent omissions in the Code of Federal Regulations (CFR), and to delete obsolete information. The technical amendments made by this final rule are editorial in nature and are intended to provide accuracy and clarity to the agency's regulations.
This rule is effective March 30, 2001.
Rhonda Rhoda Kane, Office of Nutritional Products, Labeling and Dietary Supplements (HFS–821), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202–205–4168.
FDA is making technical amendments in its regulations under parts 101, 102, 106, 107, 130, 146, 165, and 190 (21 CFR parts 101, 102, 106, 107, 130, 146, 165, and 190). Specifically, as a result of an FDA reorganization in 2000, the Office of Special Nutritionals and the Office of Food Labeling were combined to form the Office of Nutritional Products, Labeling and Dietary Supplements. Therefore, this rule updates the name and mail codes for this new office in FDA regulations on food labeling (part 101), common or usual name for nonstandardized foods (part 102), infant formula quality control procedures (part 106), infant formula (part 107), food standards (part 130), and new dietary ingredient notification requirements for dietary supplements (part 190). In parts 106 and 107, pertaining to infant formulas, this rule also corrects FDA emergency phone numbers and a regulation section citation for FDA district offices. Similarly, this rule updates the names, addresses, and other contact information for several professional organizations cited in FDA regulations on food labeling (part 101) and requirements for standardized foods (part 146). In addition, FDA discovered that minor errors and omissions were inadvertently published in the CFR affecting its regulations on food labeling (part 101), infant formulas (parts 106 and 107), and requirements for standardized foods (part 165). This rule makes the needed corrections. Finally, due to the passage of time, certain food labeling provisions for juices (§ 101.17) are now obsolete and are removed from FDA regulations by this rule.
This final regulation makes the noted technical amendments. The final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. The changes addressed in this final rule are as follows:
1. FDA's recent reorganization resulted in changes in the names of several of its offices, mail codes, phone numbers, and staff contacts cited in its regulations. This rule amends parts 101, 102, 106, 107, 130, and 190 to incorporate all of these types of changes and other minor corrections as noted below:
• Throughout part 101, pertaining to food labeling, the Office of Food Labeling (HFS–150) or the Center for Food Safety and Applied Nutrition (HFS–150) is cited as the FDA office responsible for this part's provisions. The new name and mail code for the Office of Food Labeling are the Office of Nutritional Products, Labeling and Dietary Supplements (HFS–800). The new mail code for the Center for Food Safety and Applied Nutrition pertaining to part 101 is (HFS–800). The new FDA office name and mail code are substituted for the old ones wherever they appear in part 101.
• In § 101.93(a)(1), dietary supplement manufacturers, packers or distributors are required to notify FDA no later than 30 days post marketing about any structure or function claims made on the labeling of their dietary supplements. The name and mail code of the FDA office to contact for this purpose are changed from Office of Special Nutritionals (HFS–450) to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS–810).
• In § 102.23(c)(5), pertaining to requirements for peanut spreads, the FDA mail code for the Center for Food Safety and Applied Nutrition is changed from (HFS–150) to (HFS–800).
• In § 106.120(a), pertaining to notification requirements for new formulations and reformulations of infant formulas, the FDA mail code for the Center for Food Safety and Applied Nutrition is changed from (HFS–450) to (HFS–830).
• In § 106.20(b), the FDA emergency phone number for manufacturers to call to report adulterated or misbranded infant formulas is changed from 202–737–0448 to 301–443–1240. Also in § 106.120(b), the regulatory section citation for a list of FDA district offices for manufacturers to contact to report this infant formula problem is currently erroneously stated in two places as § 5.115 and is corrected to read § 5.215.
• In § 107.50(e)(1), pertaining to notification requirements for exempt infant formulas, the FDA mail code for the Center for Food Safety and Applied Nutrition is changed from (HFS–450) to (HFS–830).
• In § 107.50(e)(2), the FDA emergency phone number for manufacturers to call to report adulterated or misbranded exempt infant formulas is changed from 202–737–0448 to 301–443–1240. Also in § 107.50(e)(2), the regulatory section citation for a list of FDA district offices for manufacturers to contact to report this problem is currently erroneously
• In §§ 107.230(e), 170.240(b), and 107.250, pertaining to infant formula recalls, notification requirements for violative infant formulas, and the termination of an infant formula recall, respectively, the regulatory section citation for a list of FDA district offices for manufacturers to contact to report these situations is currently erroneously stated one or more times as § 5.115 and is corrected to read § 5.215. Also, in § 107.240(b), the FDA emergency phone number for manufacturers to call to report violative infant formula is changed from 202–857–8400 to 301–443–1240.
• In § 130.17(c), the regulations currently state the Chief, Food Standards Branch, Office of Food Labeling, Center for Food Safety and Applied Nutrition (HFS–158) as the FDA contact to whom a request for a temporary permit must be filed. This temporary permit is for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity. The new FDA contact for filing such a permit is the Team Leader, Conventional Foods Team, Division of Standards and Labeling Regulations, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS–822).
• In 190.6(a), the FDA name and mail code for manufacturers or distributors to submit a premarket notification for a dietary supplement containing a new dietary ingredient are changed from the Office of Special Nutritionals (HFS–450) to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS–820).
2. A final rule, published in the
3. A final rule, published in the
4. In an amendment to § 101.17 published in the
5. A final rule, published in the
6. In § 165.110(b)(2) and (b)(4)(i)(C), pertaining to the microbiological and chemical quality testing of bottled water, the regulations currently state the address for the American Public Health Association as 1015 15th (or Fifteenth) St. NW., Washington, DC 20005. The American Public Health Association is the source of copies of a resource incorporated by reference for analyzing the quality of water. The new address for the American Public Health Association is 800 I St. NW., Washington, DC 20001. This rule amends part 165 to reflect the new address of the American Public Health Association.
7. In § 165.110(b)(4)(iii)(E), (b)(4)(iii)(E)(
Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because these amendments are merely correcting nonsubstantive errors.
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Beverages, Food grades and standards, Food labeling, Frozen foods, Oils and fats, Onions, Potatoes, Seafood.
Food grades and standards, Infants and children, Nutrition, Reporting and recordkeeping requirements.
Food labeling, Infants and children, Nutrition, Reporting and recordkeeping requirements, Signs and symbols.
Food additives, Food grades and standards.
Food grades and standards, Fruit juices.
Beverages, Bottled water, Food grades and standards.
Food additives, Reporting and recordkeeping requirements.
15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.
2. Part 101 is amended by removing the words “Office of Food Labeling (HFS–150)” wherever they appear and by adding in their place “Office of Nutritional Products, Labeling and Dietary Supplements (HFS–800)”, and by removing the old mail code “(HFS–150)” after the Center for Food Safety and Applied Nutrition wherever it appears and by adding in its place the new mail code “(HFS–800)”.
3. Section 101.4
4. Section 101.14
5. Section 101.17
6. Section 101.54
7. Section 101.93
8. Section 101.100
21 U.S.C. 321, 343, 371.
10. Section 102.23
21 U.S.C. 321, 350a, 371.
(b) * * * This notification shall be made, by telephone, to the Director of the appropriate Food and Drug Administration district office specified in § 5.215 of this chapter. After normal business hours (8 a.m. to 4:30 p.m.) the FDA emergency number, 301–443–1240, shall be used. The manufacturer shall send a followup written confirmation to the Center for Food Safety and Applied Nutrition (HFS–605), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, and to the appropriate Food and Drug Administration district office specified in §5.215.
21 U.S.C. 321, 343, 350a, 371.
(e) * * *
(2) * * * This notification shall be made, by telephone, to the Director of the appropriate FDA district office specified in § 5.215 of this chapter. After normal business hours (8 a.m. to 4:30 p.m.), the FDA emergency number, 301–443–1240, shall be used. The manufacturer shall send a followup written confirmation to the Center for Food Safety and Applied Nutrition (HFS–605), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, and to the appropriate FDA district office specified in § 5.215.
15. Section 107.230
16. Section 107.240
17. Section 107.250
21 U.S.C. 321, 336, 341, 343, 371.
19. Section 130.17
21 U.S.C. 321, 341, 343, 348, 371, 379e.
21. Section 146.132
21 U.S.C. 321, 341, 343, 343–1, 348, 349, 371, 379e.
a. In paragraph (b)(2) by removing the words “American Public Health Association, 1015 15th St. NW., Washington, DC 20005” and by adding in their place “American Public Health Association, 800 I St. NW., Washington, DC 20001”;
b. In paragraph (b)(4)(i)(C) by removing the words “American Public Health Association, 1015 Fifteenth St. NW., Washington, DC 20005” and by adding in their place “American Public Health Association, 800 I St. NW., Washington, DC 20001”;
c. In paragraph (b)(4)(iii)(E) by removing the words “National Technical Information Service (NTIS), U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161” and by adding in their place “National Technical Information Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161”;
d. In paragraph (b)(4)(iii)(E)(
e. In paragraph (b)(4)(iii)(E)(
Secs. 201(ff), 301, 402, 413, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 350b, 371).
25. Section 190.6