[Federal Register Volume 84, Number 162 (Wednesday, August 21, 2019)]
[Rules and Regulations]
[Pages 43501-43502]
[FR Doc No: 2019-18109]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2019-0714]

Drawbridge Operation Regulation; New River, Fort Lauderdale, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from drawbridge regulations;
request for comments.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Florida East Coast Railway (FEC)
Railroad Bridge across the New River, mile 2.5, at Fort Lauderdale,
Florida. This deviation is necessary to test a change to the drawbridge
operation schedule to determine whether a permanent change to the
schedule is needed. Under this deviation, the bridge shall not be
closed more than 60 combined minutes in each consecutive 120-minute
block of time, and at no time will this bridge be closed to navigation
for more than 60 consecutive minutes of time. This deviation supports
ongoing negotiations between the railroad and maritime stakeholders as
the parties discuss a Final Rule that reasonably meets their interests.

DATES: This deviation is effective from 12:01 a.m. on August 20, 2019,
to 11:59 p.m. on October 18, 2019.
    Comments must reach the Coast Guard on or before September 19,
2019.

ADDRESSES: You may submit comments identified by docket number USCG-
2019-0714 using Federal eRulemaking Portal at http://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this test
deviation, call or email LT Samuel Rodriguez-Gonzalez, U.S. Coast
Guard, Sector Miami Waterways Management Division; telephone 305-535-
4307, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background, Purpose and Legal Basis

    The Florida East Coast Railway (FEC) Railroad Bridge across the New
River, mile 2.5, at Fort Lauderdale, Florida is a single-leaf bascule
railroad bridge with a 4 foot vertical clearance at mean high water in
the closed position. The normal operating schedule for the bridge is
found in 33 CFR 117.313(c). There has been an increase in rail traffic
over the bridge in recent years due the start of passenger rail
service. This test deviation provides a block schedule for the bridge
to operate allowing for a more consistent operating schedule.
    The draw shall operate as follows:
    (1) The bridge shall be constantly tended.
    (2) The bridge tender will utilize a VHF-FM radio to communicate on
channels 9 and 16 and may be contacted by telephone at<PHONE_NUMBER>.
    (3) Signs will be posted displaying VHF radio contact information
and

telephone numbers for the bridge tender and dispatch. A countdown clock
giving notice of time remaining before bridge closure shall remain at
the bridge site and must be visible for maritime traffic.
    (4) A bridge log will be maintained including, at a minimum, bridge
opening and closing times.
    (5) When the draw is in the fully open position, green lights will
be displayed to indicate that vessels may pass.
    (6) When a train approaches, the lights go to flashing red then the
draw lowers and locks.
    (7) After the train has cleared the bridge, the draw opens and the
lights return to green.
    (8) The bridge shall not be closed more than 60 minutes combined in
each consecutive 120-minute block of time beginning at 12:01 a.m. each
day. At no time will the bridge be closed to navigation for more than
60 consecutive minutes of time.
    (9) The bridge shall remain open to maritime traffic when trains
are not crossing.
    Vessels able to pass through the bridge in the closed position may
do so at anytime. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels to pass. The Coast
Guard will also inform the users of the waterways through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessel operators can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

II. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacynotice.

    Dated: August 19, 2019.
Barry Dragon,
Director, Bridge Branch, Seventh Coast Guard District.
[FR Doc. 2019-18109 Filed 8-19-19; 4:15 pm]
 BILLING CODE 9110-04-P


[Federal Register: March 17, 2010 (Volume 75, Number 51)]
[Notices]
[Page 12760-12761]
[DOCID:fr17mr10-80]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-P-0318]

Determination That CERNEVIT-12 (Multivitamins for Infusion) Was
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY:  Food and Drug Administration

ACTION:  Notice

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SUMMARY:  The Food and Drug Administration (FDA) has determined that
CERNEVIT-12, multivitamins for infusion (retinol palmitate
corresponding to retinol (Vitamin A) 3500 international units (I.U.),
cholecalciferol (Vitamin D3) 200 I.U., DL alpha-tocopherol
10.2 milligrams (mg) corresponding to alpha-tocopherol (Vitamin E) 11.2
I.U., ascorbic acid (Vitamin C) 125 mg, nicotinamide (Vitamin
B3) 46 mg, dexpanthenol 16.15 mg corresponding to
pantothenic acid (Vitamin B5) 17.25 mg, pyridoxine
hydrochloride 5.5 mg corresponding to pyridoxine (Vitamin
B6) 4.53 mg, riboflavin sodium phosphate 5.67 mg
corresponding to riboflavin (Vitamin B2) 4.14 mg,
cocarboxylase tetrahydrate 5.8 mg corresponding to thiamine (Vitamin
B1) 3.51 mg, folic acid 414 micrograms (mcg), D-biotin 60
mcg, and cyanocobalamin (Vitamin B12) 5.5 mcg), (hereinafter
CERNEVIT-12 (multivitamins for infusion)), was withdrawn from sale for
reasons of safety or effectiveness. FDA therefore will not accept or
approve abbreviated new drug applications (ANDAs) for CERNEVIT-12
(multivitamins for infusion).

FOR FURTHER INFORMATION CONTACT:  Nancy Hayes, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6354, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:  In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984, Public Law No. 98-
417 (the 1984 Amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 Amendments include what is now section 505(j)(7)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)) (the
act), which requires FDA to publish a list of all approved drugs. FDA
publishes this list as part of the ``Approved Drug Products With
Therapeutic Equivalence Evaluations,'' which generally is known as the
``Orange Book.'' Under FDA regulations (part 314 (21 CFR part 314)),
drugs are removed from the list if the agency withdraws or suspends
approval of the drug's NDA or ANDA (Sec.  314.162(a)(1)) or if FDA
determines that the listed drug was withdrawn from sale for reasons of
safety or effectiveness (Sec.  314.162(a)(2)).
    Under Sec.  314.161(a)(1), the agency must determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness before an ANDA

that refers to that listed drug may be approved. FDA may not approve an
ANDA that references a listed drug that the agency has determined was
withdrawn for reasons of safety or effectiveness (Sec.
314.127(a)(11)).
    CERNEVIT-12 (multivitamins for infusion) is the subject of NDA 20-
924, held by Baxter Health Corp. (Baxter). FDA approved the NDA on
April 6, 1999, as an application under section 505(b)(2) of the act (21
U.S.C. 355(b)(2)), relying in part upon literature and the agency's
prior findings of safety and efficacy for a listed parenteral
multivitamin drug product. CERNEVIT-12 (multivitamins for infusion) is
indicated as a daily multivitamin maintenance dosage for adults and
children age 11 years and older receiving parenteral nutrition, and for
situations in which administration by the intravenous route is
required.
    Adult parenteral multivitamin drug products were reviewed for
efficacy under the Drug Efficacy Study Implementation (DESI) program.
Under this program, implemented in response to the 1962 amendments to
the act requiring demonstration of effectiveness (The Kefauver-Harris
Amendments, Public Law No. 87-781 (1962)), the National Academy of
Sciences-National Research Council (NAS-NRC) undertook a study of some
4,000 drug formulations for the express purpose of assessing the
efficacy of the products. Upon consideration of the findings and
recommendations of the NAS-NRC, FDA set forth in the Federal Register
its conclusions and assessment of whether and under what circumstances
a drug product is considered ``effective'' for use as required by the
act.
    In the initial DESI notice of July 27, 1972, addressing parenteral
multivitamin preparations, FDA announced its conclusion that parenteral
multivitamin preparations as then formulated lacked substantial
evidence of effectiveness because they did not contain certain
essential vitamins, or they contained certain vitamins in doses that
were too high or too low (37 FR 15027, July 27, 1972). Because of the
critical medical importance of these preparations and the lack of
alternative drug products, FDA notified manufacturers and distributors
of parenteral multivitamin products in December 1972 that the agency
would allow these products to remain on the market pending the
development and testing of new formulations and the resolution of
complex technical and medical issues (37 FR 26623, December 14, 1972).
    On September 17, 1984, FDA announced the parenteral multivitamin
formulations the agency had determined to be effective and the
conditions for marketing those products (49 FR 36446, September 17,
1984). The agency subsequently modified the conditions for marketing an
effective adult parenteral multivitamin drug product in 2000 (65 FR
21200, April 20, 2000). In that ``upgrade'' notice, FDA announced
several changes to the product formulation including increases in the
dosage amounts of Vitamins B1, B6, C, and folic
acid, and amended portions of the ``Conditions for Marketing and
Approval'' for parenteral multivitamin products set forth in the
September 17, 1984, notice to reflect the changes (Id. at 21201).
    In the Federal Register of August 18, 2003, FDA announced that it
was withdrawing approval of NDA 20-924 in response to Baxter's
withdrawal request dated December 18, 2002 (68 FR 49481, August 18,
2003). As a result, CERNEVIT-12 (multivitamins for infusion) was moved
to the ``Discontinued Drug Product List'' section of the Orange Book.
    Strides Arcolab Limited submitted a citizen petition under Sec.
314.161(b) of the regulations (Docket No. FDA-2009-P-0318) requesting
that FDA determine whether the NDA for CERNEVIT-12 (multivitamins for
infusion) had been withdrawn from sale for reasons of safety or
effectiveness. After considering the citizen petition and reviewing
agency records, FDA has determined that CERNEVIT-12 (multivitamins for
infusion) was withdrawn from sale for reasons of safety or
effectiveness.
    Specifically, we have carefully reviewed our files for records
concerning the withdrawal of CERNEVIT-12 (multivitamins for infusion),
including the NDA file for this product. We also have independently
evaluated relevant literature and data for possible postmarketing
adverse event reports. Agency records did not contain any clinical
reviews describing safety issues associated with CERNEVIT-12
(multivitamins for infusion), and postmarketing safety reports did not
raise any safety concerns.
    FDA has determined, however, that CERNEVIT-12 (multivitamins for
infusion) was not reformulated to comply with the April 20, 2000,
Federal Register upgrade notice before it was withdrawn from the
market. As described in that notice, adult parenteral multivitamin drug
products must contain higher doses of Vitamins B1,
B6, C, and folic acid than the dosages contained in
CERNEVIT-12 (multivitamins for infusion) (65 FR 21201).
    Because CERNEVIT-12 (multivitamins for infusion) is not in
compliance with current FDA standards for adult parenteral multivitamin
drug products, the agency has determined under Sec.  314.161 that
CERNEVIT-12 (multivitamins for infusion) was withdrawn from sale for
reasons of safety or efficacy. (57 FR 17950 at 17956, April 28, 1992)
(``if the NDA or ANDA holder fails to comply with [the DESI upgrade]
notice, the NDA or ANDA product is not considered to be approved for
effectiveness and cannot be a listed drug''). The Discontinued Drug
Product List delineates, among other items, products that have been
discontinued from marketing for reasons other than safety or
effectiveness. Therefore, CERNEVIT-12 (multivitamins for infusion) will
be removed from the Discontinued Drug Product List section of the
Orange Book (Sec.  314.162(a)(2)). In addition, FDA will not accept or
approve ANDAs that refer to CERNEVIT-12 (multivitamins for infusion)
(21 CFR 314.127(a)(11)).

    Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5748 Filed 3-16-10; 8:45 am]
BILLING CODE 4160-01-S