82 FR 12531 - DSM Biomedical; Filing of Color Additive Petition
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 42 (March 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 42 (March 6, 2017)
| Page Range | 12531-12531 | |
| FR Document | 2017-04188 |
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)] [Proposed Rules] [Page 12531] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04188] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2017-C-0935] DSM Biomedical; Filing of Color Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of high purity carbon black for coloring ultra-high molecular weight polyethylene sutures for use in general surgery. DATES: The color additive petition was filed on January 27, 2017. FOR FURTHER INFORMATION CONTACT: Joseph M. Thomas, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-796-9465. SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 7C0310), submitted by DSM Biomedical, 735 Pennsylvania Dr., Exton, PA 19341. The petition proposes to amend the color additive regulations in 21 CFR part 73, Listing of Color Additives Exempt From Certification, to provide for the safe use of high purity carbon black for coloring ultra-high molecular weight polyethylene sutures for use in general surgery. We have determined under 21 CFR 25.32(l) 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: February 28, 2017. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2017-04188 Filed 3-3-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Proposed Rules 12531
long. 145°29′05″ W.; to lat. 63°56′54″ N., long. 145°39′25″ W.; to lat. 63°57′32″ N., DEPARTMENT OF HEALTH AND
long. 145°29′02″ W.; to lat. 63°56′33″ N., long. 145°39′25″ W.; to the point of beginning HUMAN SERVICES
long. 145°27′43″ W.; to lat. 63°56′40″ N., by following Jarvis Creek.
long. 145°39′26″ W.; to lat. 63°57′20″ N., Designated altitudes. 15,000 feet MSL to
long. 145°39′25″ W.; to lat. 63°57′32″ N., Food and Drug Administration
FL220.
long. 145°39′25″ W.; to the point of beginning
by following Jarvis Creek. Time of designation. 0700–1900 local time 21 CFR Part 73
Designated altitudes. 6,000 feet MSL to but Monday–Friday; other times by NOTAM.
not including 15,000 feet MSL. Controlling agency. FAA, Anchorage,
ARTCC. [Docket No. FDA–2017–C–0935]
Time of designation. 0700–1900 local time
Monday–Friday; other times by NOTAM. Using agency. U.S. Army, AK (USARAK),
Controlling agency. FAA, Anchorage, DSM Biomedical; Filing of Color
Commanding General, Joint Base Elmendorf-
ARTCC. Richardson (JBER), AK.
Additive Petition
Using agency. U.S. Army, AK (USARAK),
Commanding General, Joint Base Elmendorf- R–2201H Fort Greely, AK [New] AGENCY: Food and Drug Administration,
Richardson (JBER), AK. BOUNDARIES. Beginning at lat. 63°55′56″ N., HHS.
R–2201E Fort Greely, AK [New] long. 145°24′57″ W.; to lat. 63°56′33″ N., ACTION: Notice of petition.
Boundaries. Beginning at lat. 63°55′56″ N., long. 145°27′43″ W.; to lat. 63°56′40″ N.,
long. 145°24′57″ W.; to lat. 63°56′33″ N., long. 145°39′26″ W.; to lat. 63°56′20″ N.,
SUMMARY: The Food and Drug
long. 145°27′43″ W.; to lat. 63°56′40″ N., long. 145°39′26″ W.; to lat. 63°56′20″ N.,
long. 145°44′41″ W.; to lat. 63°56′20″ N.,
Administration (FDA or we) is
long. 145°39′26″ W.; to lat. 63°56′20″ N.,
long. 145°39′26″ W.; to lat. 63°56′20″ N., long. 145°44′49″ W.; to lat. 63°52′54″ N., announcing that we have filed a
long. 145°44′41″ W.; to lat. 63°56′20″ N., long. 145°44′50″ W.; to lat. 63°52′55″ N., petition, submitted by DSM Biomedical,
long. 145°44′49″ W.; to lat. 63°52′54″ N., long. 145°42′56″ W.; to lat. 63°51′09″ N., proposing that the color additive
long. 145°44′50″ W.; to lat. 63°52′55″ N., long. 145°42′52″ W.; to lat. 63°51′01″ N., regulations be amended to provide for
long. 145°42′56″ W.; to lat. 63°51′09″ N., long. 145°33′04″ W.; to the point of beginning the safe use of high purity carbon black
long. 145°42′52″ W.; to lat. 63°51′01″ N., for coloring ultra-high molecular weight
by following Granite Creek.
long. 145°33′04″ W.; to the point of beginning
by following Granite Creek. Designated altitudes. 15,000 feet MSL to polyethylene sutures for use in general
Designated altitudes. 6,000 feet MSL to but FL220. surgery.
not including 15,000 feet MSL. Time of designation. 0700–1900 local time
Monday–Friday; other times by NOTAM. DATES: The color additive petition was
Time of designation. 0700–1900 local time
Monday–Friday; other times by NOTAM. Controlling agency. FAA, Anchorage, filed on January 27, 2017.
Controlling agency. FAA, Anchorage, ARTCC. FOR FURTHER INFORMATION CONTACT:
ARTCC. Using agency. U.S. Army, AK (USARAK),
Using agency. U.S. Army, AK (USARAK),
Joseph M. Thomas, Center for Food
Commanding General, Joint Base Elmendorf- Safety and Applied Nutrition (HFS–
Commanding General, Joint Base Elmendorf- Richardson (JBER), AK.
Richardson (JBER), AK. 265), Food and Drug Administration,
R–2201J Fort Greely, AK [New] 5001 Campus Dr., College Park, MD
R–2201F Fort Greely, AK [New]
Boundaries. Beginning at lat. 63°51′01″ N., 20740, 301–796–9465.
Boundaries. Beginning at lat. 63°51′01″ N.,
long. 145°33′04″ W.; to lat. 63°51′09″ N., long. 145°33′04″ W.; to lat. 63°51′09″ N., SUPPLEMENTARY INFORMATION: Under
long. 145°42′52″ W.; to lat. 63°51′10″ N., long. 145°42′52″ W.; to lat. 63°51′10″ N., section 721(d)(1) of the Federal Food,
long. 145°43′50″ W.; to lat. 63°50′58″ N., long. 145°43′50″ W.; to lat. 63°50′58″ N., Drug, and Cosmetic Act (21 U.S.C.
long. 145°43′48″ W.; to lat. 63°50′15″ N., long. 145°43′48″ W.; to lat. 63°50′15″ N.,
long. 145°43′49″ W.; to lat. 63°50′16″ N.,
379e(d)(1)), we are giving notice that we
long. 145°43′49″ W.; to lat. 63°50′16″ N.,
long. 145°44′22″ W.; to lat. 63°49′22″ N., have filed a color additive petition (CAP
long. 145°44′22″ W.; to lat. 63°49′22 N., long.
long. 145°44′35″ W.; to lat. 63°47′35″ N., 145°44′35″ W.; to lat. 63°47′35″ N., long.
7C0310), submitted by DSM Biomedical,
long. 145°45′05″ W.; to lat. 63°46′58″ N., 145°45′05″ W.; to lat. 63°46′58 N., long. 735 Pennsylvania Dr., Exton, PA 19341.
long. 145°45′13″ W.; to lat. 63°46′56″ N., The petition proposes to amend the
145°45′13″ W.; to lat. 63°46′56″ N., long.
long. 145°37′10″ W.; to lat. 63°46′57″ N., color additive regulations in 21 CFR
long. 145°36′31″ W.; to lat. 63°47′43″ N., 145°37′10″ W.; to lat. 63°46′57″ N., long.
long. 145°35′08″ W.; to lat. 63°47′45″ N., 145°36′31″ W.; to lat. 63°47′43″ N., long. part 73, Listing of Color Additives
long. 145°35′04″ W.; to the point of beginning 145°35′08″ W.; to lat. 63°47′45″ N., long. Exempt From Certification, to provide
by following Granite Creek. 145°35′04″ W.; to the point of beginning by for the safe use of high purity carbon
Designated altitudes. 6,000 feet MSL to but following Granite Creek. black for coloring ultra-high molecular
not including 15,000 feet MSL. Designated altitudes. 15,000 feet MSL to weight polyethylene sutures for use in
Time of designation. 0700–1900 local time FL220. general surgery.
Monday–Friday; other times by NOTAM. Time of designation. 0700–1900 local time
Controlling agency. FAA, Anchorage, We have determined under 21 CFR
Monday–Friday; other times by NOTAM.
ARTCC. 25.32(l) that this action is of a type that
Controlling agency. FAA, Anchorage,
Using agency. U.S. Army, AK (USARAK), does not individually or cumulatively
Commanding General, Joint Base Elmendorf- ARTCC.
Using agency. U.S. Army, AK (USARAK), have a significant effect on the human
Richardson (JBER), AK.
Commanding General, Joint Base Elmendorf- environment. Therefore, neither an
R–2201G Fort Greely, AK [New] Richardson (JBER), AK. environmental assessment nor an
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Boundaries. Beginning at lat. 63°58′49″ N., environmental impact statement is
long. 145°41′15″ W.; to lat. 63°58′45″ N., Issued in Washington, DC, on February 27,
required.
long. 145°35′06″ W.; to lat. 63°58′08″ N., 2017.
long. 145°35′05″ W.; to lat. 63°58′09″ N., Rodger A. Dean Jr., Dated: February 28, 2017.
long. 145°31′07″ W.; to lat. 63°57′17″ N., Manager, Airspace Policy Group. Dennis M. Keefe,
long. 145°31′05″ W.; to lat. 63°57′17″ N., Director, Office of Food Additive Safety,
[FR Doc. 2017–04187 Filed 3–3–17; 8:45 am]
long. 145°29′05″ W.; to lat. 63°56′54″ N., Center for Food Safety and Applied Nutrition.
long. 145°29′02″ W.; to lat. 63°56′33″ N., BILLING CODE 4910–13–P
long. 145°27′43″ W.; to lat. 63°56′40″ N., [FR Doc. 2017–04188 Filed 3–3–17; 8:45 am]
long. 145°39′26″ W.; to lat. 63°57′20″ N., BILLING CODE 4164–01–P
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Document Created: 2017-03-04 00:06:35
Document Modified: 2017-03-04 00:06:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notice of petition. | |
| Dates | The color additive petition was filed on January 27, 2017. | |
| Contact | Joseph M. Thomas, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-796-9465. | |
| FR Citation | 82 FR 12531 |
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