# Denial of approval of a PMA.
**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 change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
**DATES:**
This rule is effective November 14, 2014.
**FOR FURTHER INFORMATION CONTACT:**
Sarah Kotler, Freedom of Information Staff, Food and Drug Administration, 301-796-8975, address available on the Agency's Web site at *http://www.fda.gov.*
**SUPPLEMENTARY INFORMATION:**
FDA is making technical amendments in the Agency's regulations under 21 CFR parts 5, 10, 14, 20, 21, 314, 350, 516, and 814 as a result of a recent office move. The office name and address was “Division of Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857”. The new office name and address is listed on the Agency's Web site at *http://www.fda.gov.* The Freedom of Information Staff's new Public Reading Room number is listed on the Agency's Web site at *http://www.fda.gov.* 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**
Authority delegations (Government agencies), Imports, Organization and functions (Government agencies).
Administrative practice and procedure, News media.
Administrative practice and procedure, Advisory committees, Color additives, Drugs, Radiation protection.
Confidential business information, Courts, Freedom of Information, Government employees.
Privacy.
Administrative practice and procedure, Confidential business information, Drugs, Reporting and recordkeeping requirements.
Labeling, Over-the-counter drugs.
Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.
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, 20, 21, 314, 350, 516, and 814 are amended as follows:
**21 CFR Part 5**
**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.
**21 CFR Part 5**
2. In § 5.1110, revise paragraph (b) to read as follows:
§ 5.1110
(b) *Freedom of Information Staff.* The Freedom of Information Staff's Public Reading Room is located at the address available on the Agency's Web site at *http://www.fda.gov.*
**21 CFR Part 10**
**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.
**21 CFR Part 10**
§ 10.85
4. Section 10.85 is amended in paragraph (d)(4) by removing “(ELEM-1029)” and adding in its place “(the Freedom of Information Staff's address is available on the Agency's Web site at *http://www.fda.gov* )”.
§ 10.90
5. Section 10.90 is amended in paragraph (d) by removing “(ELEM-1029)” and adding in its place “(the Freedom of Information Staff's address is available on the Agency's Web site at *http://www.fda.gov* )”.
**21 CFR Part 10**
§ 10.95
6. Section 10.95 is amended in paragraphs (b)(2), (c)(2), (d)(2), (d)(7), and (d)(8) by removing “(ELEM-1029)” and adding in its place “(the Freedom of Information Staff's address is available on the Agency's Web site at *http://www.fda.gov* )”.
**21 CFR Part 14**
**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, Pub. L. 113-54.
**21 CFR Part 14**
§ 14.65
8. Section 14.65 is amended in paragraph (c) by removing “(ELEM-1029)” and by adding in its place “(the Freedom of Information Staff's address is available on the Agency's Web site at *http://www.fda.gov* )”.
**21 CFR Part 20**
**PART 20—PUBLIC INFORMATION**
9. 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.
§ 20.3
10. Section 20.3 is amended in paragraph (b) by removing “(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857” and adding in its place ” at the address located on the Agency's Web site at *http://www.fda.gov.* ”
11. In § 20.26, revise paragraph (b) to read as follows:
§ 20.26
(b) Each such index will be made available by accessing the Agency's Web site at *http://www.fda.gov.* A printed copy of each index is available by writing or visiting the Freedom of Information Staff's address on the Agency's Web site at *http://www.fda.gov.*
§ 20.30
12. Section 20.30 is amended in paragraph (a) by removing “(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857” and adding in its place “at the address located on the Agency's Web site at *http://www.fda.gov.* ”
13. In § 20.40, revise paragraph (a) to read as follows:
§ 20.40
(a) All requests for Food and Drug Administration records shall be made in writing by mailing or delivering the request to the Freedom of Information Staff at the address on the Agency's Web site at *http://www.fda.gov* or by faxing it to the fax number listed on the Agency's Web site at *http://www.fda.gov.* 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.
**21 CFR Part 20**
§ 20.107
14. Section 20.107 is amended in paragraph (a) by removing “(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857” and adding in its place “at the address located on the Agency's Web site at *http://www.fda.gov.* ”
15. In § 20.120, revise paragraph (a) to read as follows:
§ 20.120
(a) The Freedom of Information Staff and the Division of Dockets Management Public Reading Room are located at the same address. Both are located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. The telephone number for the Division of Docket Management is 301-827-6860; the telephone number for the Freedom of Information Staff's Public Reading Room is located at the address on the Agency's Web site at *http://www.fda.gov.* Both public reading rooms are open from 9 a.m. to 4 p.m., Monday through Friday, excluding legal public holidays.
**21 CFR Part 21**
**PART 21—PROTECTION OF PRIVACY**
16. 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
17. Section 21.32 is amended in paragraph (b)(2) in the second sentence by removing “(HFA-400), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857” and by adding in its place “HR-BETHPL RM7114, HFA-705, 7700 Wisconsin Ave., 7th & 8th floors, Bethesda, MD 20814” and in the third sentence by removing “(ELEM-1029)” and by adding in its place “(the Privacy Act Coordinator is part of the Freedom of Information Staff, the address for which is located on the Agency Web site at *http://www.fda.gov* )”.
**21 CFR Part 21**
§ 21.40
18. Section 21.40 is amended in paragraph (b) by removing “(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857” and by adding in its place “(address is located on the Agency Web site at *http://www.gov.fda* )”.
**21 CFR Part 21**
§ 21.41
19. Section 21.41 is amended in paragraphs (c) and (e) by removing “(ELEM-1029)” and by adding in its place “(address is located on the Agency Web site at *http://www.gov.fda* )”.
§ 21.43
20. Section 21.43 is amended in paragraph (a)(2) by removing “at the address shown in § 20.30 of this chapter” and by adding in its place “(address is located on the Agency's Web site at *http://www.fda.gov* )”.
**21 CFR Part 21**
§ 21.52
21. Section 21.52 is amended in paragraph (a) by removing “, Rm. 14-71, 5600 Fishers Lane, Rockville, MD 20857” and by adding in its place “(see the address on the Agency's Web site at *http://www.fda.gov* )”.
**21 CFR Part 314**
**PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG**
22. 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.
23. In § 314.53, in paragraph (e), revise the last sentence to read as follows:
§ 314.53
(e) * * * A request for copies of the file shall be sent in writing to the Freedom of Information Staff at the address listed on the Agency's Web site at *http://www.fda.gov.*
**21 CFR Part 350**
**PART 350—ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE**
24. 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
**21 CFR Part 350**
25. Section 350.60 is amended by removing “(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857” and adding in its place “(address is located on the Agency's Web site at *http://www.fda.gov.* ”
**21 CFR Part 516**
**PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES**
26. The authority citation for part 516 continues to read as follows:
**Authority:**
21 U.S.C. 360ccc-1, 360ccc-2, 371.
27. In § 516.157, revise paragraph (a) to read as follows:
§ 516.157
(a) FDA will make the list of indexed drugs available through the FDA Web site at *http://www.fda.gov.* A printed copy can be obtained by writing to the Freedom of Information Staff or by visiting FDA's Freedom of Information Staff's Public Reading Room at the address listed on the Agency's Web site at *http://www.fda.gov.*
**21 CFR Part 814**
**PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES**
28. 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.
**21 CFR Part 814**
29. In § 814.45, revise paragraph (d)(2) to read as follows:
§ 814.45
(d) * * *
(2) A request for copies of the current PMA approvals and denials document and copies of summaries of safety and effectiveness shall be sent in writing to the Freedom of Information Staff's address listed on the Agency's Web site at *http://www.fda.gov.*
Dated: November 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.