Rules and Regulations. Final rule; technical amendments

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BILLING CODE 6750-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814 [Docket No. FDA-2011-N-0318] Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration

(FDA)is amending the Agency's regulations to reflect changes to the Division of Freedom of Information's office name, address, telephone number, and fax number and the Division of Freedom of Information Public Reading room's fax and room number. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations. DATES: This rule is effective June 1, 2011. FOR FURTHER INFORMATION CONTACT: Fred Sadler, Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 301-796-8975. SUPPLEMENTARY INFORMATION: FDA is making technical amendments in the Agency's regulations under 21 CFR parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814 as a result of a recent office move. The former address, telephone number, and fax number was: rm. 6-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857, telephone: 301-827-6567, FAX: 301-443-1726. The new address is: Division of Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, telephone: 301-796-3900, FAX: 301-796-9267. The Division of Freedom of Information Public Reading Room number is 1050. Publication of this document constitutes final action of these changes under the Administrative Procedures Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because these amendments are merely correcting nonsubstantive errors. List of Subjects 21 CFR Part 5 Authority delegations (Government agencies), Imports, Organization and functions (Government agencies). 21 CFR Part 10 Administrative practice and procedure, News media. 21 CFR Part 14 Administrative practice and procedure, Advisory committees, Color additives, Drugs, Radiation protection. 21 CFR Part 19 Conflict of interests. 21 CFR Part 20 Confidential business information, Courts, Freedom of Information, Government employees. 21 CFR Part 21 Privacy. 21 CFR Part 314 Administrative practice and procedure, Confidential business information, Drugs, Reporting and recordkeeping requirements. 21 CFR Part 350 Labeling, Over-the-counter drugs. 21 CFR Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Part 814 Administrative practice and procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814 are amended as follows: PART 5—ORGANIZATION 1. The authority citation for 21 CFR part 5 continues to read as follows: Authority: 5 U.S.C. 552; 21 U.S.C. 301-397. 2. Revise § 5.1110(b) to read as follows: § 5.1110 FDA public information offices.

(b)*Division of Freedom of Information.* The Division of Freedom of Information Public Reading Room is located in rm. 1050, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857; Telephone: 301-796-3900. PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES 3. The authority citation for 21 CFR part 10 continues to read as follows: Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264. § 10.85 [Amended] 4. In § 10.85(d)(4), remove “Freedom of Information Staff (HFI-35)” and in its place add “Division of Freedom of Information (ELEM-1029)”. § 10.90 [Amended] 5. In § 10.90(d), remove “Freedom of Information Staff (HFI-35),” and in its place add “Division of Freedom of Information (ELEM-1029)”. § 10.95 [Amended] 6. In § 10.95, remove “Freedom of Information Staff” and “Freedom of Information Staff (HFI-35)” everywhere they appear and in their places add “Division of Freedom of Information (ELEM-1029)”. PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 7. The authority citation for 21 CFR part 14 continues to read as follows: Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155. § 14.65 [Amended] 8. In § 14.65(c), remove “Freedom of Information Staff (HFI-35)” and in its place add “Division of Freedom of Information (ELEM-1029)”. PART 19—STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST 9. The authority citation for 21 CFR part 19 continues to read as follows: Authority: 21 U.S.C. 371. § 19.10 [Amended] 10. In § 19.10(d) introductory text, remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information”. PART 20—PUBLIC INFORMATION 11. The authority citation for 21 CFR part 20 continues to read as follows: Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1. 12. Revise § 20.3(b) to read as follows: § 20.3 Certification and authentication of Food and Drug Administration records.

(b)A request for certified copies of records or for authentication of records shall be sent in writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. 13. Revise § 20.26(b), to read as follows: § 20.26 Indexes of certain records.

(b)Each such index will be made available through the Internet at *http://www.fda.gov.* A printed copy of each index is available by writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, or by visiting the Division of Freedom of Information Public Reading Room, located in rm. 1050, at the same address. 14. Revise § 20.30 to read as follows: § 20.30 Food and Drug Administration Division of Freedom of Information.

(a)The office responsible for Agency compliance with the Freedom of Information Act and this part is the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

(b)All requests for Agency records shall be sent in writing to this office. 15. In § 20.40, revise paragraph (a); and in paragraph (c), remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information” to read as follows: § 20.40 Filing a request for records.

(a)All requests for Food and Drug Administration records shall be made in writing by mailing or delivering the request to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857; or by faxing it to 301-796-9267. All requests must contain the postal address and telephone number of the requester and the name of the person responsible for payment of any fees that may be charged. § 20.41 [Amended] 16. In § 20.41 paragraph (a), paragraph

(b)introductory text, and paragraph (c), remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information”. § 20.44 [Amended] 17. In § 20.44(e), remove “Freedom of Information Staff” and in its place add “Division of Freedom of Information”. 18. In § 20.107(a), revise the second sentence to read as follows: § 20.107 Food and Drug Administration manuals.

(a)* * * An index of all such manuals is available by writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857; or by visiting the Division of Freedom of Information Public Reading Room, located in rm. 1050, at the same address. * * * 19. In § 20.108, remove “Freedom of Information Public Room” everywhere it appears and in its place add “Division of Freedom of Information Public Reading Room”. 20. In § 20.120, revise paragraph (a); paragraph

(b)introductory text; and paragraph (b)(4) to read as follows: § 20.120 Records available in Food and Drug Administration Public Reading Rooms.

(a)The Food and Drug Administration operates two public reading rooms. The Division of Freedom of Information Public Reading Room is located in rm. 1050, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857; the telephone number is 301-796-3900. The Division of Dockets Management Public Reading Room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852; the telephone number is 301-827-6860. Both public reading rooms are open from 9 a.m. to 4 p.m., Monday through Friday, excluding legal public holidays.

(b)The following records are available at the Division of Freedom of Information Public Reading Room:

(4)Indexes of records maintained in the Division of Freedom of Information Public Reading Room; and PART 21—PROTECTION OF PRIVACY 21. The authority citation for 21 CFR part 21 continues to read as follows: Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a. § 21.32 [Amended] 22. In 21.32(b)(2), remove “(HFI-30)” and in its place add “(ELEM-1029)”. § 21.40 [Amended] 23. In § 21.40(b), remove “(HFI-30), Food and Drug Administration, 5600 Fishers Lane,” and in its place add “(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,”. § 21.41 [Amended] 24. In § 21.41, remove “Freedom of Information Staff” everywhere it appears and in its place add “Division of Freedom of Information (ELEM-1029)”; and remove “(HFI-30)” everywhere it appears. § 21.43 [Amended] 25. In § 21.43(a)(2), remove “Freedom of Information Staff public room” and in its place add “Division of Freedom of Information Public Reading Room”. PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG 26. The authority citation for 21 CFR part 314 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e. 27. In § 314.53(e), revise the last two sentences to read as follows: § 314.53 Submission of patent information.

(e)* * * Patent information received by the Agency between monthly publication of supplements to the list will be placed on public display in FDA's Division of Freedom of Information. A request for copies of the file shall be sent in writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. PART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 28. The authority citation for 21 CFR part 350 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. § 350.60 [Amended] 29. In § 350.60, in the last sentence, remove “FOI Staff (HFI-35), 5600 Fishers Lane, rm. 12A-16,” and in its place add “Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,”. PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 30. The authority citation for part 516 continues to read as follows: Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. § 516.157 [Amended] 31. In § 516.157(a), remove “Freedom of Information Staff or by visiting the FDA Freedom of Information Public Reading Room” and in its place add “Division of Freedom of Information or by visiting FDA's Division of Freedom of Information Public Reading Room”. PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES 32. The authority citation for 21 CFR part 814 continues to read as follows: Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381. § 814.45 [Amended] 33. In § 814.45(d)(2), remove “Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane,” and in its place add “Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,”. Dated: May 18, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-13488 Filed 5-31-11; 8:45 am]

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