Richard C. Theuer; Filing of Food Additive Petition and Citizen Petition, 43093-43094 [2013-17330]

Download as PDF wreier-aviles on DSK5TPTVN1PROD with PROPOSALS Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Proposed Rules information will not be provided to the FAA. Individuals are concerned that public release of the information could result in potential misuses of the information that could affect them negatively. If the FAA does not receive the information, the FAA and the public will be deprived of the opportunity to make the safety improvements that receipt of the information otherwise enables. Corrective action under T–SAP and ATSAP can be accomplished without disclosure of protected information. For example, for acceptance under each program, the reporting individual must comply with ERC recommendations for corrective action, such as additional training. If the individual fails to complete corrective action in a manner satisfactory to all members of the ERC, the event may be referred to an appropriate office within the FAA for any additional investigation, reexamination, and/or action, as appropriate. (2) The FAA may release T–SAP and ATSAP information submitted to the agency, as specified in Part 193 and this proposed Order. For example, to explain the need for changes in FAA policies, procedures, and regulations, the FAA may disclose de-identified, summarized information that has been derived from T–SAP and ATSAP reports or extracted from the protected information listed under paragraph 4b. The FAA may disclose de-identified, summarized T–SAP and ATSAP information that identifies a systemic problem in the National Airspace System, when a party needs to be advised of the problem in order to take corrective action. Under the current version of FAA Order JO 7200.20, reported events and possible violations may be subject to investigation, reexamination, and/or action. Although the report itself and the content of the report are not used as evidence, the FAA may use the knowledge of the event or possible violation to generate an investigation, and, in that regard, the information is not protected from disclosure. To withhold information from such limited release would be inconsistent with the FAA’s safety responsibilities. In addition, reports that appear to involve possible criminal activity, substance abuse, controlled substances, alcohol, or intentional falsification will be referred to an appropriate FAA office for further handling. The FAA may use such reports for enforcement purposes, and will refer such reports to law enforcement agencies, if appropriate. To withhold information in these circumstances would be inconsistent with the agency’s safety responsibilities VerDate Mar<15>2010 14:49 Jul 18, 2013 Jkt 229001 because it could prevent, or at least diminish, the FAA’s ability to effectively address egregious misconduct. f. Summary of how the FAA will distinguish information protected under part 193 from information the FAA receives from other sources. (1) All T–SAP and ATSAP reports are clearly labeled as such. Each individual must submit their own report. 5. Designation The FAA designates the information described in paragraph 4b to be protected from disclosure in accordance with 49 U.S.C. 40123 and 14 CFR part 193. Issued in Washington, DC, on July 10, 2013. Michael P. Huerta, Administrator, Federal Aviation Administration. [FR Doc. 2013–17401 Filed 7–18–13; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration the color additive regulations in 21 CFR part 74 Listing of Color Additives Subject to Certification to provide for the safe use of External D&C Violet No. 2 in coloring externally applied drug products. Sensient Technologies Corporation has now withdrawn the petition without prejudice to a future filing (21 CFR 71.6(c)(2)). Dated: July 16, 2013. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2013–17382 Filed 7–18–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 172 and 182 [Docket Nos. FDA–2013–F–0700 and FDA– 2013–P–0472] Richard C. Theuer; Filing of Food Additive Petition and Citizen Petition AGENCY: Sensient Technologies Corporation; Withdrawal of Color Additive Petition Food and Drug Administration, HHS. ACTION: Notice of withdrawal. The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a color additive petition (CAP 8C0261) proposing that the color additive regulations be amended to provide for the safe use of External D&C Violet No. 2 in coloring externally applied drug products. FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740– 3835, 240–402–1309. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of August 24, 1998 (63 FR 45073), FDA announced that a color additive petition (CAP 8C0261) had been filed by WarnerJenkinson Co., Inc. (now part of Sensient Cosmetic Technologies, a unit of Sensient Technologies Corporation), 107 Wade Ave., South Plainfield, NJ 07080. The petition proposed to amend SUMMARY: PO 00000 Frm 00003 Fmt 4702 Notice of petition. The Food and Drug Administration (FDA or we) is announcing that Richard C. Theuer, Ph.D., has filed a petition proposing that the food additive regulations be amended to prohibit the use of carrageenan and salts of carrageenan in infant formula. In addition, the petitioner has submitted a citizen petition, under FDA regulations, requesting that we amend the generally recognized as safe (GRAS) regulations to prohibit the use of Chondrus extract (carrageenin) in infant formula. FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740– 3835, 240–402–1075. SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that Richard C. Theuer, Ph.D., 7904 Sutterton Ct., Raleigh, NC 27615, has filed a food additive petition (FAP 3A4798; Docket No. FDA–2013–F– 0700). The petition proposes to amend the food additive regulations in 21 CFR 172.620 and 172.626 to prohibit the use of carrageenan and salts of carrageenan in infant formula. In addition, Dr. Theuer has submitted a citizen petition, under 21 CFR 10.30, requesting that 21 SUMMARY: [Docket No. FDA–1998–C–0381] (Formerly Docket No. 98C–0676) AGENCY: Food and Drug Administration, HHS. ACTION: 21 CFR Part 74 Sfmt 4702 43093 E:\FR\FM\19JYP1.SGM 19JYP1 43094 Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Proposed Rules CFR 182.7255 of the GRAS regulations be amended to prohibit the use of Chondrus extract (carrageenin) in infant formula (Docket No. FDA–2013–P– 0472). (Carrageenin is an alternate name for carrageenan.) Although the petitioner has submitted both a food additive petition and a citizen petition, for reasons of administrative efficiency, we may address all aspects of the petitions under the procedures established in section 409 of the FD&C Act and regulations issued under that section. We have determined under 21 CFR 25.32(m) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. Dated: July 16, 2013. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2013–17330 Filed 7–18–13; 8:45 am] BILLING CODE 4160–01–P LIBRARY OF CONGRESS Copyright Royalty Board 37 CFR Part 384 [Docket No. 2012–1 CRB Business Establishments II] Determination of Rates and Terms for Business Establishment Services Copyright Royalty Board, Library of Congress. ACTION: Proposed rule. AGENCY: The Copyright Royalty Judges are publishing for comment proposed regulations that set the rates and terms for the making of an ephemeral recording of a sound recording by a business establishment service for the period January 1, 2014, through December 31, 2018. DATES: Comments and objections are due no later than August 19, 2013. ADDRESSES: Comments and objections may be sent electronically to crb@loc.gov. In the alternative, send an original, five copies, and an electronic copy on a CD either by mail or hand delivery. Please do not use multiple means for transmission. Comments and objections may not be delivered by an overnight delivery service other than the U.S. Postal Service Express Mail. If by mail (including overnight delivery), comments and objections must be addressed to: Copyright Royalty Board, wreier-aviles on DSK5TPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 14:49 Jul 18, 2013 Jkt 229001 P.O. Box 70977, Washington, DC 20024– 0977. If hand delivered by a private party, comments and objections must be brought between 8:30 a.m. and 5 p.m. to the Copyright Office Public Information Office, Library of Congress, James Madison Memorial Building, Room LM– 401, 101 Independence Avenue SE., Washington, DC 20559–6000. If delivered by a commercial courier, comments and objections must be delivered between 8:30 a.m. and 4 p.m. to the Congressional Courier Acceptance Site located at 2nd and D Street NE., Washington, DC, and the envelope must be addressed to Copyright Royalty Board, Library of Congress, James Madison Memorial Building, LM–403, 101 Independence Avenue SE., Washington, DC 20559–6000. FOR FURTHER INFORMATION CONTACT: LaKeshia Keys, Program Specialist, by telephone at (202) 707–7658 or email at crb@loc.gov. In 1995, Congress enacted the Digital Performance in Sound Recordings Act, Public Law 104–39, which created an exclusive right for copyright owners of sound recordings, subject to certain limitations, to perform publicly sound recordings by means of certain digital audio transmissions. Among the limitations on the performance right was the creation of a statutory license for nonexempt, noninteractive digital subscription transmissions. 17 U.S.C. 114(d). The scope of the section 114 statutory license was expanded in 1998 upon the passage of the Digital Millennium Copyright Act of 1998 (DMCA), Public Law 105–34, in order to allow for the public performance of a sound recording when made in accordance with the terms and rates of the statutory license, 17 U.S.C. 114(d), by a preexisting satellite digital audio radio service or as part of an eligible nonsubscription transmission. In addition to expanding the section 114 license, the DMCA also created a statutory license for the making of an ‘‘ephemeral recording’’ of a sound recording by certain transmitting organizations. 17 U.S.C. 112(e). This license allows entities that transmit performance of sound recordings to business establishments, pursuant to the limitations set forth in section 114(d)(1)(C)(iv), to make an ephemeral recording of a sound recording for a later transmission. Id. The license also provides a means by which a transmitting entity with a statutory license under section 114(f) can make more than one phonorecord permitted SUPPLEMENTARY INFORMATION: PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 under the exemption set forth in section 112(a). 17 U.S.C. 112(e). Chapter 8 of the Copyright Act requires the Copyright Royalty Judges (Judges) to conduct proceedings every five years to determine the rates and terms for ‘‘the activities described in section 112(e)(1) relating to the limitation on exclusive rights specified by section 114(d)(1)(C)(iv).’’ 1 17 U.S.C. 801(b)(1), 804(b)(2). In accordance with section 804(b)(2), the Judges commenced a proceeding to set rates and terms for the making of ephemeral sound recordings by a business establishment service on January 5, 2007, 72 FR 584, and published in the Federal Register on March 27, 2008, final regulations setting those rates and terms. 73 FR 16199. Therefore, the next proceeding was to be commenced in January 2012. 17 U.S.C. 804(b)(2). Accordingly, the Judges published a notice commencing the current proceeding and requesting interested parties to submit their petitions to participate. 77 FR 133 (Jan. 3, 2012). Petitions to Participate were received from: Pandora Media, Inc.; Music Choice; DMX, Inc.; Muzak LLC; Music Reports, Inc.; Clear Channel Broadcasting, Inc.; SoundExchange, Inc.; and Sirius XM Radio, Inc. The Judges set the timetable for the threemonth negotiation period, see 17 U.S.C. 803(b)(3), and directed the participants to submit their written direct statements no later than November 16, 2012. Subsequently, the Judges granted the participants’ request to extend the deadline to November 29, 2012, in order to allow the participants to finalize a settlement agreement. See Order Granting Joint Motion for Extension of Time for Filing Written Direct Statements, Docket No. 2012–1 CRB Business Establishments II (Nov. 14, 2012). On November 29, 2012, the Judges received a Motion to Adopt Settlement stating that all participants had reached a settlement obviating the need for a hearing. Section 801(b)(7)(A) of the Copyright Act authorizes the Judges to adopt rates and terms negotiated by ‘‘some or all of the participants in a proceeding at any time during the proceeding’’ provided they are submitted to the Judges for approval. This section provides in part that the Judges must provide to both non-participants and participants to the rate proceeding who ‘‘would be bound 1 Prior to the enactment of the Copyright Royalty and Distribution Reform Act of 2004, which established the Copyright Royalty Judges, rates and terms for the statutory license under section 112(e) were set under the Copyright Arbitration Royalty Panel system, which was administered by the Librarian of Congress. E:\FR\FM\19JYP1.SGM 19JYP1

Agencies

[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Proposed Rules]
[Pages 43093-43094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17330]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 172 and 182

[Docket Nos. FDA-2013-F-0700 and FDA-2013-P-0472]


Richard C. Theuer; Filing of Food Additive Petition and Citizen 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that Richard C. Theuer, Ph.D., has filed a petition proposing that the 
food additive regulations be amended to prohibit the use of carrageenan 
and salts of carrageenan in infant formula. In addition, the petitioner 
has submitted a citizen petition, under FDA regulations, requesting 
that we amend the generally recognized as safe (GRAS) regulations to 
prohibit the use of Chondrus extract (carrageenin) in infant formula.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(b)(5)), we are 
giving notice that Richard C. Theuer, Ph.D., 7904 Sutterton Ct., 
Raleigh, NC 27615, has filed a food additive petition (FAP 3A4798; 
Docket No. FDA-2013-F-0700). The petition proposes to amend the food 
additive regulations in 21 CFR 172.620 and 172.626 to prohibit the use 
of carrageenan and salts of carrageenan in infant formula. In addition, 
Dr. Theuer has submitted a citizen petition, under 21 CFR 10.30, 
requesting that 21

[[Page 43094]]

CFR 182.7255 of the GRAS regulations be amended to prohibit the use of 
Chondrus extract (carrageenin) in infant formula (Docket No. FDA-2013-
P-0472). (Carrageenin is an alternate name for carrageenan.)
    Although the petitioner has submitted both a food additive petition 
and a citizen petition, for reasons of administrative efficiency, we 
may address all aspects of the petitions under the procedures 
established in section 409 of the FD&C Act and regulations issued under 
that section.
    We have determined under 21 CFR 25.32(m) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: July 16, 2013.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2013-17330 Filed 7-18-13; 8:45 am]
BILLING CODE 4160-01-P
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