Sunscreen Drug Products for Over-the-Counter Human Use; Correction, 16220-16222 [2019-07712]

Download as PDF 16220 Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Proposed Rules VOR/DME Fix VORTAC T–295 POORK, VA to Bangor, POORK, VA KREGG, VA HOUKY, VA TAPPA, VA COLIN, VA SHLBK, MD LOUIE, MD GRACO, MD VYSOR, MD BAABS, MD Lancaster, PA (LRP) DUMMER, PA HAILS, PA SNOWY, PA KRAZE, PA LYTEL, PA Wilkes-Barre, PA (LVZ) LAAYK, PA KERRI, NY PRNCE, NY SAGES, NY TALCO, NY WIGAN, NY BOWAN, NY MOBBS, MA SASHA, MA MOLDS, MA WHATE, MA WARIC, MA Keene, NH (EEN) TAPSE, NH Concord, NH (CON) SATAN, ME Kennebunk, ME (ENE) BRNNS, ME RAZZR, ME Bangor, ME (BGR) * * * * * Issued in Washington, DC, on April 10, 2019. M. Colby Abbott, Acting Manager, Airspace Policy Group. [FR Doc. 2019–07597 Filed 4–17–19; 8:45 am] BILLING CODE 4910–13–P (Lat. 42°10′41.81″ N, long. 074°57′24.99″ W) (Lat. 42°26′26.98″ N, long. 074°25′48.33″ W) (Lat. 42°44′50.21″ N, long. 073°48′11.47″ W) ME (BGR) [Amended] (Lat. WP (Lat. WP (Lat. Fix (Lat. Fix (Lat. WP (Lat. Fix (Lat. Fix (Lat. WP (Lat. WP (Lat. VORTAC (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. VORTAC (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. Fix (Lat. VORTAC (Lat. Fix (Lat. VOR/DME (Lat. Fix (Lat. VOR/DME (Lat. Fix (Lat. Fix (Lat. VORTAC (Lat. 36°34′11.34″ 36°51′07.95″ 37°19′55.98″ 37°58′12.66″ 38°05′59.23″ 38°20′16.21″ 38°36′44.33″ 38°56′29.81″ 39°02′03.86″ 39°19′51.39″ 40°07′11.91″ 40°28′10.68″ 40°34′13.43″ 40°45′05.77″ 40°50′13.14″ 40°55′48.79″ 41°16′22.10″ 41°28′32.64″ 41°50′37.49″ 41°58′24.75″ 42°02′46.33″ 42°03′45.97″ 42°05′06.33″ 42°06′23.14″ 42°07′30.84″ 42°07′58.70″ 42°12′30.91″ 42°26′10.03″ 42°37′42.00″ 42°47′39.40″ 43°04′16.55″ 43°13′11.23″ 43°23′09.13″ 43°25′32.42″ 43°54′08.64″ 44°13′16.51″ 44°50′30.46″ N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, N, long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. long. 077°35′21.39″ 077°25′17.57″ 077°07′57.63″ 076°50′40.62″ 076°39′50.85″ 076°26′10.51″ 076°18′04.37″ 076°11′59.22″ 076°14′59.88″ 076°24′40.87″ 076°17′28.66″ 076°06′40.18″ 076°03′31.77″ 075°57′51.63″ 075°55′10.83″ 075°52′14.42″ 075°41′22.07″ 075°28′57.31″ 074°44′14.93″ 074°28′12.25″ 074°19′10.33″ 074°06′27.85″ 073°48′53.89″ 073°31′28.95″ 073°15′36.59″ 073°08′55.39″ 073°03′13.39″ 072°45′41.96″ 072°30′37.72″ 072°17′30.40″ 071°49′38.92″ 071°34′31.63″ 070°48′11.07″ 070°36′48.69″ 069°56′42.81″ 069°35′12.25″ 068°52′26.27″ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 201 [Docket No. FDA–1978–N–0018 (formerly Docket No. FDA–1978–N–0038)] RIN 0910–AF43 Sunscreen Drug Products for Over-theCounter Human Use; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction. The Food and Drug Administration (FDA) is correcting a proposed rule relating to the regulation of over-the-counter (OTC) sunscreen monograph products that appeared in the Federal Register of February 26, 2019. The document was published jbell on DSK30RV082PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 16:59 Apr 17, 2019 Jkt 247001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4725 W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) W) with formulas that were illegible. These corrections are being made to improve the accuracy of the proposed rule. Submit either electronic or written comments on the proposed rule by June 27, 2019. DATES: FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993, 240–402– 4246. In the Federal Register of February 26, 2019 (84 FR 6204), in FR Doc. 2019–03019, on pages 6267 through 6270, the following corrections are made: 1. On page 6267, in the first column, the formula under § 201.327(i)(2)(ii)(B) is corrected to read: SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P E:\FR\FM\18APP1.SGM 18APP1 EP18AP19.004</GPH> Delancey, NY (DNY) OAKIL, NY Albany, NY (ALB) Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Proposed Rules 2. On page 6268, in the second column, the formula under § 201.327(i)(3)(ii)(C)(2) is corrected to read: 3. On page 6268, in the second column, the formulas under § 201.327(i)(3)(ii)(D)(2)(i) are corrected to read: 16221 4. On page 6269, in the third column, the formula under § 201.327(i)(7)(i) is corrected to read: 5. On page 6269, in the third column, the formulas under § 201.327(i)(7)(ii) are corrected to read: EP18AP19.008</GPH> EP18AP19.009</GPH> 6. On page 6270, in the second column, the formula under § 201.327(j)(4)(ii) is corrected to read: EP18AP19.007</GPH> EP18AP19.006</GPH> VerDate Sep<11>2014 16:59 Apr 17, 2019 Jkt 247001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\18APP1.SGM 18APP1 EP18AP19.005</GPH> jbell on DSK30RV082PROD with PROPOSALS 7. On page 6270, in the third column, the formulas under § 201.327(j)(5)(i) are corrected to read: 16222 Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Proposed Rules 8. On page 6270, in the third column, the formula under § 201.327(j)(7) is corrected to read: 9. On page 6270, in the third column, the formula under § 201.327(j)(8) is corrected to read: BILLING CODE 4164–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1978–N–0018 (formerly Docket No. FDA–1978–N–0038)] FDA is extending the comment period on the proposed rule published February 26, 2019 (84 FR 6204). Submit either electronic or written comments by June 27, 2019. RIN 0910–AF43 ADDRESSES: DATES: 21 CFR Parts 201, 310, 347, and 352 Sunscreen Drug Products for Over-theCounter Human Use; Extension of Comment Period AGENCY: Food and Drug Administration, jbell on DSK30RV082PROD with PROPOSALS HHS. Proposed rule; extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of February 26, 2019. SUMMARY: VerDate Sep<11>2014 16:59 Apr 17, 2019 Jkt 247001 You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 27, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 27, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). E:\FR\FM\18APP1.SGM 18APP1 EP18AP19.012</GPH> [FR Doc. 2019–07712 Filed 4–17–19; 8:45 am] Electronic Submissions EP18AP19.011</GPH> Dated: April 12, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. In the proposed rule, FDA requested comments on its proposals relating to the regulation of over-the-counter (OTC) sunscreen monograph products. These proposals described the conditions under which the Agency proposes that OTC sunscreen monograph products are generally recognized as safe and effective and not misbranded. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. EP18AP19.010</GPH> Elsewhere in this issue of the Federal Register, FDA is extending the comment period on the proposed rule.

Agencies

[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Proposed Rules]
[Pages 16220-16222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. FDA-1978-N-0018 (formerly Docket No. FDA-1978-N-0038)]
RIN 0910-AF43


Sunscreen Drug Products for Over-the-Counter Human Use; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
proposed rule relating to the regulation of over-the-counter (OTC) 
sunscreen monograph products that appeared in the Federal Register of 
February 26, 2019. The document was published with formulas that were 
illegible. These corrections are being made to improve the accuracy of 
the proposed rule.

DATES:  Submit either electronic or written comments on the proposed 
rule by June 27, 2019.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993, 240-402-
4246.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 26, 2019 
(84 FR 6204), in FR Doc. 2019-03019, on pages 6267 through 6270, the 
following corrections are made:
    1. On page 6267, in the first column, the formula under Sec.  
201.327(i)(2)(ii)(B) is corrected to read:
 BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TP18AP19.004


[[Page 16221]]


    2. On page 6268, in the second column, the formula under Sec.  
201.327(i)(3)(ii)(C)(2) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.005

    3. On page 6268, in the second column, the formulas under Sec.  
201.327(i)(3)(ii)(D)(2)(i) are corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.006

    4. On page 6269, in the third column, the formula under Sec.  
201.327(i)(7)(i) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.007

    5. On page 6269, in the third column, the formulas under Sec.  
201.327(i)(7)(ii) are corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.008

    6. On page 6270, in the second column, the formula under Sec.  
201.327(j)(4)(ii) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.009

    7. On page 6270, in the third column, the formulas under Sec.  
201.327(j)(5)(i) are corrected to read:

[[Page 16222]]

[GRAPHIC] [TIFF OMITTED] TP18AP19.010

    8. On page 6270, in the third column, the formula under Sec.  
201.327(j)(7) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.011

    9. On page 6270, in the third column, the formula under Sec.  
201.327(j)(8) is corrected to read:
[GRAPHIC] [TIFF OMITTED] TP18AP19.012

    Elsewhere in this issue of the Federal Register, FDA is extending 
the comment period on the proposed rule.

    Dated: April 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07712 Filed 4-17-19; 8:45 am]
 BILLING CODE 4164-01-C
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