[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Rules and Regulations]
[Pages 48700-48703]
[FR Doc No: 2016-17501]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

[Docket No. FDA-2014-N-0002]

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 57 approved new
animal drug applications (NADAs) and 14 approved abbreviated new animal
drug applications (ANADAs) from Elanco Animal Health, A Division of Eli
Lilly & Co. to Elanco US, Inc.

DATES: This rule is effective July 26, 2016.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has
informed FDA that it has transferred ownership of, and all rights and
interest in, the 71 approved NADAs and ANADAs in table 1 to Elanco US,
Inc., 2500 Innovation Way, Greenfield, IN 46140.

   Table 1--NADAs and ANADAs Transferred From Elanco Animal Health, a
             Division of Eli Lilly & Co. to Elanco US, Inc.
------------------------------------------------------------------------
                                                              21 CFR
            File No.                   Product name           Section
------------------------------------------------------------------------
010-918........................  HYGROMIX 8 (hygromycin          558.274
                                  B) Type A medicated
                                  article.
011-948........................  HYGROMIX 2.4                    558.274
                                  (hygromycin B) Type A
                                  medicated article.
012-491........................  TYLAN 100 (tylosin)            522.2640
                                  Injection.
012-548........................  TYLAN (tylosin                  558.274
                                  phosphate)/HYGROMIX
                                  (hygromycin B).
012-965........................  TYLAN (tylosin)                522.2640
                                  Injection.
013-076........................  TYLAN (tylosin                 520.2640
                                  tartrate) Soluble
                                  Powder.
013-162........................  TYLAN Premix No. 10             558.625
                                  (tylosin phosphate)
                                  Type A medicated
                                  article.
013-388........................  TYLAN (tylosin                  558.274
                                  phosphate)/HYGROMIX
                                  (hygromycin B).
015-166........................  TYLAN 100 Premix                558.625
                                  (tylosin phosphate)
                                  Type A medicated
                                  article.
038-878........................  COBAN 45, 60, 90, 110           558.355
                                  (monensin) Type A
                                  medicated article.
041-275........................  TYLAN 40 Sulfa-G                558.630
                                  (tylosin phosphate and
                                  sulfamethazine) Type A
                                  medicated article.
047-933........................  COBAN (monensin)/               558.355
                                  BACIFERM (bacitracin
                                  Zn).
049-463........................  COBAN (monensin)/BMD            558.355
                                  (bacitracin
                                  methylenedisalicyclate
                                  ).
095-735........................  RUMENSIN 80 and 90              558.355
                                  (monensin) Type A
                                  medicated article.
104-646........................  RUMENSIN (monensin)/            558.355
                                  TYLAN (tylosin
                                  phosphate).
106-964........................  APRALAN (apramycin              520.110
                                  sulfate) Soluble
                                  Powder.
110-315........................  COMPONENT E-C or E-S           522.1940
                                  (progesterone and
                                  estradiol benzoate)
                                  with TYLAN.
115-732........................  STRESNIL (azaperone)            522.150
                                  Injection.
118-123........................  COMPUDOSE 200                   522.840
                                  (estradiol); ENCORE
                                  (COMPUDOSE 400).
118-980........................  MONTEBAN (narasin) Type         558.363
                                  A medicated article.
126-050........................  APRALAN 75 (apramycin           520.110
                                  sulfate) Soluble
                                  Powder.
127-507........................  TYLAN 5, 10, 20, 40             558.630
                                  Sulfa-G (tylosin
                                  phosphate and
                                  sulfamethazine) Type A
                                  medicated article.
130-736........................  COBAN (monensin) Type A         558.355
                                  medicated article.
135-468........................  Nicarbazin Type A               558.366
                                  medicated article.
135-906........................  COMPONENT E-H                   522.842
                                  (estradiol benzoate
                                  and testosterone
                                  propionate) with TYLAN.
138-952........................  MAXIBAN (narasin and            558.366
                                  nicarbazin) Type A
                                  medicated article.
140-863........................  PAYLEAN 9 and 45                558.500
                                  (ractopamine HCl) Type
                                  A medicated article.
140-872........................  POSILAC (sometribove           522.2112
                                  Zn) Injectable
                                  Suspension.
140-926........................  BMD (bacitracin                 558.366
                                  methylenedisalicyclate
                                  )/MAXIBAN (narasin and
                                  nicarbazin).
140-929........................  MICOTIL 300 (tilmicosin        522.2471
                                  phosphate) Injectable
                                  Solution.
140-937........................  BMD (bacitracin                 558.355
                                  methylenedisalicyclate
                                  )/COBAN (monensin).
140-942........................  FLAVOMYCIN                      558.366
                                  (bambermycins)/MAXIBAN
                                  (narasin and
                                  nicarbazin).
140-947........................  LINCOMIX (lincomycin            558.366
                                  HCl)/MAXIBAN (narasin
                                  and nicarbazin).
140-955........................  COBAN (monensin)/               558.355
                                  FLAVOMYCIN
                                  (bambermycins).
141-064........................  PULMOTIL 90 (tilmicosin         558.618
                                  phosphate) Type A
                                  medicated article.
141-277........................  COMFORTIS (spinosad)           520.2130
                                  Tablets.
141-298........................  SUROLAN (miconazole            524.1445
                                  nitrate, polymyxin B
                                  sulfate, prednisolone
                                  acetate) Otic
                                  Suspension.
141-321........................  TRIFEXIS (spinosad and         520.2134
                                  milbemycin oxime)
                                  Tablets.
141-110........................  COBAN (monensin)/STAFAC         558.355
                                  (virginiamycin).
141-164........................  COBAN (monensin)/TYLAN          558.355
                                  (tylosin phosphate).
141-170........................  MONTEBAN (narasin)/             558.363
                                  TYLAN (tylosin
                                  phosphate).
141-172........................  PAYLEAN (ractopamine            558.500
                                  HCl)/TYLAN (tylosin
                                  phosphate).
141-198........................  TYLAN (tylosin                  558.550
                                  phosphate)/BIO-COX
                                  (salinomycin sodium).
141-221........................  OPTAFLEXX 45                    558.500
                                  (ractopamine HCl) Type
                                  A medicated article.
141-224........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/TYLAN
                                  (tylosin phosphate).
141-225........................  OPTAFLEXX (ractopamine          558.500
                                  HCl) RUMENSIN
                                  (monensin).
141-234........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/MGA
                                  (melengestrol acetate).
141-290........................  TOPMAX 9 (ractopamine           558.500
                                  HCl) Type A medicated
                                  article.
141-233........................  OPTAFLEXX (ractopamine          558.500
                                  HCl)/RUMENSIN
                                  (monensin)/TYLAN
                                  (tylosin phosphate)/
                                  MGA (melengestrol
                                  acetate).
141-301........................  TOPMAX (ractopamine             558.500
                                  HCl)/COBAN (monensin).
141-337........................  RECUVYA (fentanyl)              524.916
                                  Topical Solution.
141-340........................  SKYCIS 100 (narasin)            558.363
                                  Type A medicated
                                  article.
141-343........................  PULMOTIL 90 (tilmicosin         558.618
                                  phosphate)/RUMENSIN 90
                                  (monensin).
141-361........................  PULMOTIL AC (tilmicosin        520.2471
                                  phosphate) Concentrate
                                  Solution.
141-392........................  IMPRESTOR                      522.1684
                                  (pegbovigrastim)
                                  Injection.
141-438........................  KAVAULT (avilamycin)             558.68
                                  Type A medicated
                                  article.
141-439........................  INTEPRITY (avilamycin)           558.68
                                  Type A medicated
                                  article.

200-221........................  COMPONENT TE-G                 522.2477
                                  (trenbolone acetate
                                  and estradiol);
                                  COMPONENT TE-G with
                                  TYLAN; COMPONENT TE-ID
                                  with TYLAN; COMPONENT
                                  TE-IS; COMPONENT TE-IS
                                  with TYLAN; COMPONENT
                                  TE-S; COMPONENT TE-S
                                  with TYLAN.
200-224........................  COMPONENT T-H                  522.2476
                                  (trenbolone acetate)
                                  with TYLAN; COMPONENT
                                  T-S with TYLAN.
200-343........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Type A medicated
                                  article.
200-346........................  COMPONENT TE-200               522.2477
                                  (trenbolone acetate
                                  and estradiol);
                                  COMPONENT TE-200 with
                                  TYLAN; COMPONENT TE-H;
                                  COMPONENT TE-H with
                                  TYLAN, COMPONENT TE-H.
200-375........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-422........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/RUMENSIN
                                  (monensin).
200-424........................  HEIFERMAX (melengestrol         558.342
                                  acetate)/OPTAFLEXX
                                  (ractopamine HCl)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-427........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/TYLAN
                                  (tylosin phosphate).
200-430........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)
                                  Liquid Premix/BOVATEC
                                  (lasalocid)/TYLAN
                                  (tylosin phosphate).
200-448........................  HEIFERMAX 500                   558.500
                                  (melengestrol acetate)/
                                  OPTAFLEXX (ractopamine
                                  HCl)/RUMENSIN
                                  (monensin).
200-451........................  HEIFERMAX 500                   558.342
                                  (melengestrol acetate)/
                                  BOVATEC (lasalocid).
200-479........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol)/
                                  RUMENSIN (monensin).
200-480........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol)/
                                  RUMENSIN (monensin)/
                                  TYLAN (tylosin
                                  phosphate).
200-483........................  HEIFERMAX 500                   558.665
                                  (melengestrol acetate)/
                                  ZILMAX (zilpaterol).
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in 21 CFR parts
520, 522, 524, and 558 to reflect these changes of sponsorship.
    Following these changes of sponsorship, Elanco Animal Health, A
Division of Eli Lilly & Co. is no longer the sponsor of any approved
application. Accordingly, the regulations are being amended to remove
this firm from the lists of sponsors of approved applications in 21 CFR
510.600(c).
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Elanco Animal Health, A Division of Eli Lilly & Co.''; and in the
table in paragraph (c)(2), remove the entry for ``000986''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.110  [Amended]

0
4. In Sec.  520.110, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  520.2130  [Amended]

0
5. In Sec.  520.2130, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  520.2134  [Amended]

0
6. In Sec.  520.2134, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  520.2471  [Amended]

0
7. In Sec.  520.2471, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  520.2640  [Amended]

0
8. In Sec.  520.2640, in paragraph (b)(1), remove ``000986'' and in its
place add ``058198''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.150  [Amended]

0
10. In Sec.  522.150, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  522.840  [Amended]

0
11. In Sec.  522.840, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  522.842  [Amended]

0
12. In Sec.  522.842, in paragraph (a)(2), remove ``000986'' and in its
place add ``058198''.

Sec.  522.1684  [Amended]

0
13. In Sec.  522.1684, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  522.1940  [Amended]

0
14. In Sec.  522.1940, in paragraph (a)(2), remove ``000986'' and in
its place add ``058198''.

Sec.  522.2112  [Amended]

0
15. In Sec.  522.2112, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  522.2471  [Amended]

0
16. In Sec.  522.2471, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  22.2476  [Amended]

0
17. In Sec.  522.2476, in paragraph (a)(1), remove ``021641'' and in
its place add ``058198''.

Sec.  522.2477  [Amended]

0
18. In Sec.  522.2477, in paragraph (b)(1), remove ``000986'' and in
its place add ``058198''.

Sec.  522.2640  [Amended]

0
19. In Sec.  522.2640, in paragraph (b)(1), remove ``000986'' and in
its place add ``058198''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
20. The authority citation for part 524 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  524.916  [Amended]

0
21. In Sec.  524.916, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  524.1445  [Amended]

0
22. In Sec.  524.1445, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
23. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

Sec.  558.68  [Amended]

0
24. In Sec.  558.68, in paragraph (b), remove ``000986'' and in its
place add ``058198''.

Sec.  558.274  [Amended]

0
25. In Sec.  558.274, in paragraph (a)(1), remove ``000986'' and in its
place add ``058198''; and in paragraphs (c)(1)(i) and (ii) and
(c)(2)(i) and (ii), in the ``Sponsor'' column, remove ``000986'' and in
its place add ``058198''.

Sec.  558.342  [Amended]

0
26. In Sec.  558.342, in paragraph (b)(2), remove ``000986'' and in its
place add ``058198''; and in paragraphs (e)(1)(i) through (iv) and
(e)(1)(ix) and (x), in the ``Sponsor'' column, remove ``000986'' and in
its place add ``058198''.

Sec.  558.355  [Amended]

0
27. In Sec.  558.355, in paragraphs (b)(1) and (2), (b)(4) through (9),
(b)(11) and (12), and (b)(14), in paragraphs (f)(1)(xiii)(b),
(f)(1)(xxi)(b), (f)(1)(xxii)(b), (f)(1)(xxviii)(b), (f)(1)(xxix)(b),
(f)(1)(xxxi)(b), paragraphs (f)(3)(i)(b)(2)(iii), (f)(3)(ii)(b),
(f)(3)(xii)(b), in paragraphs (f)(4)(ii)(b) and (f)(4)(iii)(b), and in
paragraph (f)(6)(i)(b)(2)(iii), remove ``000986'' and in its place add
``058198''.

Sec.  558.363  [Amended]

0
28. In Sec.  558.363, in paragraphs (a)(1), (3), and (8), and in
paragraphs (d)(1)(ii)(B), (d)(1)(iii)(B), (d)(1)(iv)(B), (d)(1)(v)(B),
and (d)(1)(vi)(B), remove ``000986'' and in its place add ``058198''.

Sec.  558.366  [Amended]

0
29. In Sec.  558.366, in paragraph (b), remove ``000986'' and in its
place add ``058198''; and in paragraph (d), in the six row entries
beginning in the ``Nicarbazin in grams per ton'' column with ``27 to
45'', in the ``Limitations'' and ``Sponsor'' columns, remove ``000986''
wherever it occurs and in its place add ``058198''.

Sec.  558.500  [Amended]

0
30. In Sec.  558.500, in paragraph (b), remove ``000986 and 054771''
and in its place add ``054771 and 058198''; and in paragraphs (e)(1)(i)
through (iv) and (e)(2)(i) through (xiii), in the ``Limitations'' and
``Sponsor'' columns, remove ``000986'' wherever it occurs and in its
place add ``058198''; and in paragraphs (e)(3)(i) through (iv), in the
``Sponsor'' column, remove ``000986'' wherever it occurs and in its
place add ``058198''.

Sec.  558.550  [Amended]

0
31. In Sec.  558.550, in paragraph (d)(1)(xxii)(B), remove ``000986 and
016592'' and in its place add ``016592 and 058198''.

Sec.  558.618  [Amended]

0
32. In Sec.  558.618, in paragraph (b), remove ``000986 and 016592''
and in its place add ``016592 and 058198''; and in paragraphs (e)(1)(i)
and (e)(2)(i) through (iii), in the ``Sponsor'' column, remove
``000986'' and in its place add ``058198''.

Sec.  558.625  [Amended]

0
33. In Sec.  558.625, in paragraph (b)(1), remove ``To 000986'' and in
its place add ``No. 058198''.

Sec.  558.630  [Amended]

0
34. In Sec.  558.630, in paragraph (b)(1), remove ``000986'' and in its
place add ``058198''.

Sec.  558.665  [Amended]

0
35. In Sec.  558.665, in paragraphs (e)(2), (3), (4), (5), (6), (8),
(10), (11), and (12), in the ``Limitations'' column, remove ``000986''
wherever it occurs and in its place add ``058198''; and in paragraphs
(e)(2), (3), (4), and (6), in the ``Sponsor'' column, remove ``000986''
and in its place add ``058198''.

    Dated: July 20, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-17501 Filed 7-25-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 29, 2008 (Volume 73, Number 169)]
[Notices]
[Page 50978]
[DOCID:fr29au08-86]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1782-DR]

New Hampshire; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New Hampshire (FEMA-1782-DR), dated August
11, 2008, and related determinations.

DATES: Effective Date: August 11, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 11, 2008, the President declared a major disaster under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the State
of New Hampshire resulting from severe storms, a tornado, and
flooding on July 24, 2008, is of sufficient severity and magnitude
to warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. Sec. Sec.
5121-5207 (the Stafford Act). Therefore, I declare that such a major
disaster exists in the State of New Hampshire.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas, Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act that you deem
appropriate. Consistent with the requirement that Federal assistance
be supplemental, any Federal funds provided under the Stafford Act
for Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, except for any particular projects that are eligible
for a higher Federal cost-sharing percentage under the FEMA Public
Assistance Pilot Program instituted pursuant to 6 U.S.C. Sec.  777.
If Other Needs Assistance under Section 408 of the Stafford Act is
later warranted, Federal funding under that program also will be
limited to 75 percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Philip E. Parr, of FEMA is appointed
to act as the Federal Coordinating Officer for this declared disaster.
    The following areas of the State of New Hampshire have been
designated as adversely affected by this declared major disaster:

    Belknap, Carroll, and Rockingham Counties for Public Assistance.
    All counties within the State of New Hampshire are eligible to
apply for assistance under the Hazard Mitigation Grant Program.

    (The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-20071 Filed 8-28-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register: July 25, 2008 (Volume 73, Number 144)]
[Rules and Regulations]
[Page 43350]
[DOCID:fr25jy08-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0456; Airspace Docket No. 08-AAL-15]

Revision of Class E Airspace; Prospect Creek, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action revises Class E airspace at Prospect Creek, AK, to
provide adequate controlled airspace to contain aircraft executing
Special Instrument Approach Procedures (IAPs) and Special Obstacle
Departure Procedures (ODPs). Three Special IAPs are being developed for
the Prospect Creek Airport. Addtionally, two Special IAPs and a Special
ODP are being amended. This action revises existing Class E airspace
upward from 700 feet (ft.) and 1,200 ft. above the surface at Prospect
Creek Airport, Prospect Creek, AK.

DATES: Effective Date: 0901 UTC, September 25, 2008. The Director of
the Federal Register approves this incorporation by reference action
under title 1, Code of Federal Regulations, part 51, subject to the
annual revision of FAA Order 7400.9 and publication of conforming
amendments.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, AAL-538G, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet address: http://www.alaska.faa.gov/at.

SUPPLEMENTARY INFORMATION:

History

    On Thursday, May 29, 2008, the FAA proposed to amend part 71 of the
Federal Aviation Regulations (14 CFR part 71) to revise Class E
airspace upward from 700 ft. above the surface and from 1,200 ft. above
the surface at Prospect Creek, AK (73 FR 30824). The action was
proposed in order to create Class E airspace sufficient in size to
contain aircraft while executing instrument procedures for the Prospect
Creek Airport. Class E controlled airspace extending upward from 700
ft. and 1,200 ft. above the surface in the Prospect Creek Airport area
is revised by this action.
    Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments were received. The rule is adopted as proposed.
    The area will be depicted on aeronautical charts for pilot
reference. The coordinates for this airspace docket are based on North
American Datum 83. The Class E airspace areas designated as 700/1,200
ft. transition areas are published in paragraph 6005 of FAA Order
7400.9R, Airspace Designations and Reporting Points, signed August 15,
2007, and effective September 15, 2007, which is incorporated by
reference in 14 CFR 71.1. The Class E airspace designations listed in
this document will be published subsequently in the Order.

The Rule

    This amendment to 14 CFR part 71 revises Class E airspace at the
Prospect Creek Airport, Alaska. This Class E airspace is revised to
accommodate aircraft executing new and amended instrument procedures,
and will be depicted on aeronautical charts for pilot reference. The
intended effect of this rule is to provide adequate controlled airspace
for Instrument Flight Rules (IFR) operations at the Prospect Creek
Airport, Prospect Creek, Alaska.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart 1, section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it creates Class E airspace sufficient in size to contain aircraft
executing instrument procedures for the Prospect Creek Airport and
represents the FAA's continuing effort to safely and efficiently use
the navigable airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71-- DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, signed August 15, 2007, and effective September 15, 2007, is
amended as follows:

Paragraph 6005 Class E Airspace extending upward from 700 feet or
more above the surface of the earth.

* * * * *

AAL AK E5 Prospect Creek, AK [Revised]

Prospect Creek, Prospect Creek Airport, AK
    (Lat. 66[deg]48'50'' N., long. 150[deg]38'37'' W.)

    That airspace extending upward from 700 feet above the surface
within an 11-mile radius of the Prospect Creek Airport, AK, and
extending 2 miles either side of a line from 66[deg]55'50'' N.
150[deg]32'43'' W. to 67[deg]02'47'' N. 150[deg]34'16'' W. extending
beyond the 11-mile radius, and 4.5 miles east and 4 miles west of
the 214[deg] bearing from the Prospect Creek Airport, AK, extending
from the 11-mile radius to 13 miles southwest of the Prospect Creek
Airport, AK; and that airspace extending upward from 1,200 feet
above the surface within a 72-mile radius of the Prospect Creek
Airport, AK.
* * * * *

    Issued in Anchorage, AK, on July 17, 2008.
Anthony M. Wylie,
Manager, Alaska Flight Services Information Area Group.
 [FR Doc. E8-16961 Filed 7-24-08; 8:45 am]

BILLING CODE 4910-13-P


(b), which is unnecessary and inconsistent with Sec.  60.5385(a)(1) and
(2). The commenter also believes it is inconsistent with the rule's
structure for other affected facilities.
    Second, the commenter states that the EPA is not proposing to
modify Sec.  60.5410(c)(1) (initial compliance requirements) which
states ``[d]uring the initial compliance period, you must continuously
monitor the number of hours of operation or track the number of months
since the last rod packing replacement.'' The commenter contends that
reciprocating compressor affected facilities complying with Sec.
60.5385(a)(3) cannot comply with this requirement. Thus, the commenter
believes that this requirement must be revised. Additionally, the
commenter contends that there is not an initial compliance requirement
here for compressors complying with Sec.  60.5385(a)(3); thus, it would
be inappropriate to reference the Sec.  60.5411(a) and (b)
requirements.
    Third, the commenter states that in the proposed continuous
compliance requirements in Sec.  60.5415(c)(4), the EPA proposes to
reference the initial compliance requirements in Sec.  60.5411(a) and
(b). The commenter contends that this does not make sense and does not
conform to the changes that the EPA is also proposing at Sec.
60.5416(a) and (b) (continuous cover and closed vent system
requirements).
    Fourth, the commenter states that the EPA is proposing to make
Sec.  60.5416(a) and (b) (continuous cover and closed vent system
requirements) applicable for reciprocating compressors; however, the
recordkeeping requirements associated with Sec.  60.5416(a) and (b)
have not been modified to conform to this proposed change.
Additionally, the commenter believes Sec.  60.5420(c)(6) currently
fails to reference Sec.  60.5416(a)(2). The commenter recommends that
the EPA take this opportunity to resolve this oversight.
    One commenter does not believe that the proposed application of the
closed vent system requirements to reciprocating compressors or the
routing of the rod packing equipment through a closed vent system to a
process in Sec.  60.5385(a)(3) are appropriate alternatives.

    Response: The EPA disagrees with several aspects of the comments
but also agrees with certain suggestions. The commenter states that the
reference in Sec.  60.5385(a)(3) to Sec.  60.5411(a) and (b) is not
necessary. The EPA disagrees with this comment, because we consider it
necessary to specify the standards to which a closed vent system and
cover must be designed and operated to achieve the emission reductions
sought by the rule.
    The EPA disagrees with the comment that the reference to Sec.
60.5411(a) and (b) make it inconsistent with Sec.  60.5385(a)(1) and
(2). Neither Sec.  60.5385(a)(1) nor (2) relies on additional equipment
(e.g., covers and closed vent systems) to be operated properly to
obtain the required emission reductions. Therefore, no such reference
is needed in Sec.  60.5385(a)(1) or (2).
    The EPA agrees that compliance with 60.5410(c)(1) is intended for
owners and operators that have not exercised their option to comply
with 60.5385(a)(3), and has finalized language to that effect suggested
by the commenter. The EPA has added a restrictive clause to Sec.
60.5410(c) such that Sec.  60.5410(c)(1) through (4) apply only to
sources electing to comply with Sec.  60.5385(a)(1) and (2). We made
this change because several of the provisions of Sec.  60.5410(c)(1)
through (4) are inappropriate for affected facilities that have chosen
to comply with Sec.  60.5385(a)(3) rather than (a)(1) and (2).
    The EPA agrees that owners and operators that route rod packing
emissions to a process under Sec.  60.5385(a)(3) are not subject to
Sec.  60.5410(c)(1). We have amended Sec.  60.5410(c) to specify that
owners and operators using closed vent systems and covers are not
subject to Sec.  60.5410(c)(1).
    The commenter states that requirements in Sec.  60.5411(a) and (b)
are initial compliance requirements and should not be referenced in the
continuous compliance requirements of Sec.  60.5415(c)(4). The EPA
disagrees with the commenter because there are requirements within
Sec.  60.5411(a) and (b) that require compliance beyond initial
compliance. Therefore, we believe it is necessary to specify continuous
compliance with Sec.  60.5411(a) and (b).
    The commenter states that Sec.  60.5416(a) and (b) should be
qualified so as to apply only the reciprocating compressors subject to
Sec.  60.5385(a)(3). The EPA agrees with this comment and has added
language to make this change.
    The EPA agrees that Sec.  60.5415(c)(4) is intended to describe the
requirements applicable to reciprocating compressors operating under
Sec.  60.5385(a)(3) and should refer to the continuous compliance
requirements applicable to closed vent systems and covers specified in
Sec.  60.5416(a) and (b).
    The EPA agrees with the suggested revision of 60.5420(c) (6)
through (9), and has made the changes to the regulatory text.
    Comment: One commenter also expressed support for the proposed
changes to Sec.  60.5385 to allow the emissions from reciprocating
compressors to be routed to a process, but believes other revisions,
similar to or the same as those suggested by the previous commenter,
are needed in the rule to maintain consistency with the proposed
changes. The commenter's suggestions are not repeated here but are
detailed in their comments.
    Response: As discussed in the response to a previous comment, the
EPA has made several amendments to the proposed rule language to
clarify the requirements for reciprocating compressors.

VI. Technical Corrections and Clarifications

    The EPA is finalizing corrections and clarifications to the 2012
NSPS and the 2013 storage vessel amendments including typographical and
grammatical errors, as well as incorrect dates and cross-references.
Details of the specific changes we are finalizing to the regulatory
text may be found in the docket for this action.\4\
---------------------------------------------------------------------------

    \4\ Memorandum from Moore, Bruce, U.S. EPA, to Docket ID No.
EPA-HQ-OAR-2010-0505, Technical Corrections to the Oil and Natural
Gas Sector New Source Performance Standards. June 30, 2014.
---------------------------------------------------------------------------

VII. Impacts of These Final Amendments

    Our analysis shows that owners and operators of affected facilities
would choose to install and operate the same or similar air pollution
control technologies under this action as would have been necessary to
meet the previously finalized standards. We project that these
amendments will result in no significant change in costs, emission
reductions, or benefits. Even if there were changes in costs for the
affected facilities, such changes would likely be small relative to
both the overall costs of the individual projects and the overall costs
and benefits of the final rule. Since we believe that owners and
operators would put on the same controls for this revised final rule
that they would have for the original final rule, there should not be
any incremental costs related to this final revision.

A. What are the air impacts?

    We believe that owners and operators of affected facilities will
install the same or similar control technologies to comply with the
revised standards finalized in this action as they would have installed
to comply with the previously finalized standards. Accordingly, we
believe that this final rule will not result in significant changes in
emissions of any of the regulated pollutants.

B. What are the energy impacts?

    This final rule is not anticipated to have an effect on the supply,
distribution, or use of energy. As previously stated, we believe that
owners and operators of affected facilities would install the same or
similar control technologies as they would have installed to comply
with the previously finalized standards.

C. What are the compliance costs?

    We believe there will be no significant change in compliance costs
as a result of this final rule because owners and operators of affected
facilities would install the same or similar control technologies as
they would have installed to comply with the previously finalized
standards.

D. What are the economic and employment impacts?

    Because we expect that owners and operators of affected facilities
would install the same or similar control technologies to meet the
standards finalized in this action as they would have chosen to comply
with the previously finalized standards, we do not anticipate that this
final rule will result in significant changes in emissions, energy
impacts, costs, benefits, or economic impacts. Likewise, we believe
this rule will not have any impacts on the price of electricity,
employment or labor markets, or the U.S. economy.

E. What are the benefits of the final standards?

    As previously stated, the EPA anticipates the oil and natural gas
sector will not incur significant compliance costs or savings as a
result of this action and we do not anticipate any significant emission
changes resulting from these amendments to the rule. Therefore, there
are no direct monetized benefits or disbenefits associated with this
final rule.

VIII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be

found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0673. Today's action does not change the
information collection requirements previously finalized and, as a
result, does not impose any additional information collection burden on
industry.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. The EPA has determined that none of the
small entities subject to this rule will experience a significant
impact because today's action imposes no additional compliance costs on
owners or operators of affected sources. We have therefore concluded
that this action will have no net regulatory burden for all directly
regulated small entities.

D. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action imposes no enforceable duty on any
state, local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. It will not have substantial direct effect on
tribal governments, on the relationship between the federal government
and Indian tribes or on the distribution of power and responsibilities
between the federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this action.
    Although at proposal the EPA noted that Executive Order 13175 did
not apply, the EPA solicited comment from tribes inclined to comment on
the proposed action. The EPA did not receive substantive comments from
tribes on our proposal.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because the EPA does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children.
    This action does not add to or relieve affected sources from any
requirements, and therefore has no impacts; thus, health and risk
assessments were not conducted. The public was invited to submit
comments or identify peer-reviewed studies and data that assess effects
of early life exposure to HAP from oil and natural gas sector
activities. The EPA received no substantive information on these risks.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low-income
or indigenous populations because it does not affect the level of
protection provided to human health or the environment. The basis for
this determination is that this action is a reconsideration of existing
requirements and imposes no new impacts or costs.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 60

    Administrative practice and procedure, Air pollution control,
Environmental protection, Intergovernmental relations, Reporting and
recordkeeping.

    Dated: December 19, 2014.
Gina McCarthy,
Administrator.

    For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:

PART 60--STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES

0
1. The authority citation for part 60 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart OOOO--[Amended]

0
2. Section 60.5365 is amended by revising paragraph (e) to read as
follows:

Sec.  60.5365  Am I subject to this subpart?

* * * * *
    (e) Each storage vessel affected facility, which is a single
storage vessel located in the oil and natural gas production segment,
natural gas processing segment or natural gas transmission and storage
segment, and has the potential for VOC emissions equal to or greater
than 6 tpy as determined according to this section by October 15, 2013
for Group 1 storage vessels and by April 15, 2014, or 30 days after
startup (whichever is later) for Group 2 storage vessels, except as
provided in paragraphs (e)(1) through (4) of this section. The
potential for VOC emissions must be calculated using a generally
accepted model or calculation methodology, based on the maximum average
daily throughput determined for a 30-day period of production prior to

the applicable emission determination deadline specified in this
section. The determination may take into account requirements under a
legally and practically enforceable limit in an operating permit or
other requirement established under a Federal, State, local or tribal
authority.
    (1) For each new, modified or reconstructed storage vessel
receiving liquids pursuant to the standards for gas well affected
facilities in Sec.  60.5375, including wells subject to Sec.
60.5375(f), you must determine the potential for VOC emissions within
30 days after startup of production.
    (2) A storage vessel affected facility that subsequently has its
potential for VOC emissions decrease to less than 6 tpy shall remain an
affected facility under this subpart.
    (3) For storage vessels not subject to a legally and practically
enforceable limit in an operating permit or other requirement
established under Federal, state, local or tribal authority, any vapor
from the storage vessel that is recovered and routed to a process
through a VRU designed and operated as specified in this section is not
required to be included in the determination of VOC potential to emit
for purposes of determining affected facility status, provided you
comply with the requirements in paragraphs (e)(3)(i) through (iv) of
this section.
    (i) You meet the cover requirements specified in Sec.  60.5411(b).
    (ii) You meet the closed vent system requirements specified in
Sec.  60.5411(c).
    (iii) You maintain records that document compliance with paragraphs
(e)(3)(i) and (ii) of this section.
    (iv) In the event of removal of apparatus that recovers and routes
vapor to a process, or operation that is inconsistent with the
conditions specified in paragraphs (e)(3)(i) and (ii) of this section,
you must determine the storage vessel's potential for VOC emissions
according to this section within 30 days of such removal or operation.
    (4) For each new, reconstructed, or modified storage vessel with
startup, startup of production, or which is returned to service,
affected facility status is determined as follows: If a storage vessel
is reconnected to the original source of liquids; used to replace any
storage vessel affected facility; or is installed in parallel with any
storage vessel affected facility, it is a storage vessel affected
facility subject to the same requirements as before being removed from
service, or applicable to the storage vessel affected facility being
replaced, or with which it is installed in parallel immediately upon
startup, startup of production, or return to service.
* * * * *

0
3. Section 60.5375 is amended by:
0
a. Revising paragraphs (a) introductory text and (a)(1) through (3);
0
b. Revising paragraph (b);
0
c. Revising paragraphs (f)(1)(i) and (ii); and
0
d. Revising paragraph (f)(2).
    The revisions read as follows:

Sec.  60.5375  What standards apply to gas well affected facilities?

* * * * *
    (a) Except as provided in paragraph (f) of this section, for each
well completion operation with hydraulic fracturing begun prior to
January 1, 2015, you must comply with the requirements of paragraphs
(a)(3) and (4) of this section unless a more stringent state or local
emission control requirement is applicable; optionally, you may comply
with the requirements of paragraphs (a)(1) through (4) of this section.
For each new well completion operation with hydraulic fracturing begun
on or after January 1, 2015, you must comply with the requirements in
paragraphs (a)(1) through (4) of this section. You must maintain a log
as specified in paragraph (b).
    (1) For each stage of the well completion operation, as defined in
Sec.  60.5430, follow the requirements specified in paragraph (a)(1)(i)
and (ii) of this section.
    (i) During the initial flowback stage, route the flowback into one
or more well completion vessels or storage vessels and commence
operation of a separator unless it is technically infeasible for a
separator to function. Any gas present in the initial flowback stage is
not subject to control under this section.
    (ii) During the separation flowback stage, route all recovered
liquids from the separator to one or more well completion vessels or
storage vessels, re-inject the liquids into the well or another well or
route the recovered liquids to a collection system. Route the recovered
gas from the separator into a gas flow line or collection system, re-
inject the recovered gas into the well or another well, use the
recovered gas as an on-site fuel source, or use the recovered gas for
another useful purpose that a purchased fuel or raw material would
serve. If it is infeasible to route the recovered gas as required
above, follow the requirements in paragraph (a)(3) of this section. If,
at any time during the separation flowback stage, it is not technically
feasible for a separator to function, you must comply with (a)(1)(i) of
this section.
    (2) All salable quality recovered gas must be routed to the gas
flow line as soon as practicable. In cases where salable quality gas
cannot be directed to the flow line, you must follow the requirements
in paragraph (a)(3) of this section.
    (3) You must capture and direct recovered gas to a completion
combustion device, except in conditions that may result in a fire
hazard or explosion, or where high heat emissions from a completion
combustion device may negatively impact tundra, permafrost or
waterways. Completion combustion devices must be equipped with a
reliable continuous ignition source.
* * * * *
    (b) You must maintain a log for each well completion operation at
each gas well affected facility. The log must be completed on a daily
basis for the duration of the well completion operation and must
contain the records specified in Sec.  60.5420(c)(1)(iii).
* * * * *
    (f) * * *
    (1) * * *
    (i) Each well completion operation with hydraulic fracturing at a
wildcat or delineation well.
    (ii) Each well completion operation with hydraulic fracturing at a
non-wildcat low pressure gas well or non-delineation low pressure gas
well.
    (2) Route the flowback into one or more well completion vessels and
commence operation of a separator unless it is technically infeasible
for a separator to function. Any gas present in the flowback before the
separator can function is not subject to control under this section.
You must capture and direct recovered gas to a completion combustion
device, except in conditions that may result in a fire hazard or
explosion, or where high heat emissions from a completion combustion
device may negatively impact tundra, permafrost or waterways.
Completion combustion devices must be equipped with a reliable
continuous ignition source. You must also comply with paragraphs (a)(4)
and (b) through (e) of this section.
* * * * *

0
4. Section 60.5385 is amended by:
0
a. Revising paragraph (a) introductory text; and
0
b. Adding paragraph (a)(3).
    The revision and addition read as follows:

Sec.  60.5385  What standards apply to reciprocating compressor
affected facilities?

* * * * *

    (a) You must replace the reciprocating compressor rod packing
according to either paragraph (a)(1) or (2) of this section or you must
comply with paragraph (a)(3) of this section.
* * * * *
    (3) Collect the emissions from the rod packing using a rod packing
emissions collection system which operates under negative pressure and
route the rod packing emissions to a process through a closed vent
system that meets the requirements of Sec.  60.5411(a).
* * * * *

0
5. Section 60.5390 is amended by revising paragraph (c)(2) to read as
follows:

Sec.  60.5390  What standards apply to pneumatic controller affected
facilities?

* * * * *
    (c) * * *
    (2) Each pneumatic controller affected facility constructed,
modified or reconstructed on or after October 15, 2013, at a location
between the wellhead and a natural gas processing plant or the point of
custody transfer to an oil pipeline must be tagged with the month and
year of installation, reconstruction or modification, and
identification information that allows traceability to the records for
that controller as required in Sec.  60.5420(c)(4)(iii).
* * * * *

0
6. Section 60.5395 is amended by:
0
a. Revising paragraph (d)(1)(i); and
0
b. Revising paragraph (f).
    The revisions read as follows:

Sec.  60.5395  What standards apply to storage vessel affected
facilities?

* * * * *
    (d) * * *
    (1) * * *
    (i) For each Group 2 storage vessel affected facility, you must
achieve the required emissions reductions by April 15, 2014, or within
60 days after startup, whichever is later, except as otherwise provided
below in paragraph (f) of this section. For storage vessel affected
facilities receiving liquids pursuant to the standards for gas well
affected facilities in Sec.  60.5375, you must achieve the required
emissions reductions within 60 days after startup of production as
defined in Sec.  60.5430.
* * * * *
    (f) Requirements for Group 1 and Group 2 storage vessel affected
facilities that are removed from service or returned to service. If you
remove a Group 1 or Group 2 storage vessel affected facility from
service, you must comply with paragraphs (f)(1) through (3) of this
section. A Group 1 or Group 2 storage vessel is not an affected
facility under this subpart for the period that it is removed from
service.
    (1) For a storage vessel affected facility to be removed from
service, you must comply with the requirements of paragraph (f)(1)(i)
and (ii) of this section.
    (i) You must completely empty and degas the storage vessel, such
that the storage vessel no longer contains crude oil, condensate,
produced water or intermediate hydrocarbon liquids. A storage vessel
where liquid is left on walls, as bottom clingage or in pools due to
floor irregularity is considered to be completely empty.
    (ii) You must submit a notification as required in Sec.
60.5420(b)(6)(vi) in your next annual report, identifying each storage
vessel affected facility removed from service during the reporting
period and the date of its removal from service.
    (2) If a storage vessel identified in paragraph (f)(1)(ii) of this
section is returned to service, you must determine its affected
facility status as provided in Sec.  60.5365(e).
    (3) For each storage vessel affected facility returned to service
during the reporting period, you must submit a notification in your
next annual report as required in Sec.  60.5420(b)(6)(vii), identifying
each storage vessel affected facility and the date of its return to
service.
* * * * *

0
7. Section 60.5401 is amended by revising paragraphs (d) and (e) to
read as follows:

Sec.  60.5401  What are the exceptions to the equipment leak standards
for affected facilities at onshore natural gas processing plants?

* * * * *
    (d) Pumps in light liquid service, valves in gas/vapor and light
liquid service, pressure relief devices in gas/vapor service, and
connectors in gas/vapor service and in light liquid service that are
located at a nonfractionating plant that does not have the design
capacity to process 283,200 standard cubic meters per day (scmd) (10
million standard cubic feet per day) or more of field gas are exempt
from the routine monitoring requirements of Sec. Sec.  60.482-2a(a)(1),
60.482-7a(a), 60.482-11a(a), and paragraph (b)(1) of this section.
    (e) Pumps in light liquid service, valves in gas/vapor and light
liquid service, pressure relief devices in gas/vapor service, and
connectors in gas/vapor service and in light liquid service within a
process unit that is located in the Alaskan North Slope are exempt from
the routine monitoring requirements of Sec. Sec.  60.482-2a(a)(1),
60.482-7a(a), 60.482-11a(a), and paragraph (b)(1) of this section.
* * * * *

0
8. Section 60.5410 is amended by:
0
a. Revising paragraph (c)(1);
0
b. Adding a new paragraph (c)(2); and
0
c. Revising paragraph (d)(2) to read as follows:

Sec.  60.5410  How do I demonstrate initial compliance with the
standards for my gas well affected facility, my centrifugal compressor
affected facility, my reciprocating compressor affected facility, my
pneumatic controller affected facility, my storage vessel affected
facility, and my equipment leaks and sweetening unit affected
facilities at onshore natural gas processing plants?

* * * * *
    (c) * * *
    (1) If complying with Sec.  60.5385(a)(1) or (2), during the
initial compliance period, you must continuously monitor the number of
hours of operation or track the number of months since the last rod
packing replacement.
    (2) If complying with Sec.  60.5385(a)(3), you must operate the rod
packing emissions collection system under negative pressure and route
emissions to a process through a closed vent system that meets the
requirements of Sec.  60.5411(a).
* * * * *
    (d) * * *
    (2) You own or operate a pneumatic controller affected facility
located at a natural gas processing plant and your pneumatic controller
is driven by a gas other than natural gas and therefore emits zero
natural gas.
* * * * *

0
9. Section 60.5411 is amended by:
0
a. Revising the section heading and introductory text;
0
b. Revising the heading of paragraph (a);
0
c. Revising paragraph (a)(1);
0
d. Revising paragraph (b)(3); and
0
e. Revising the heading of paragraph (c).
    The revisions read as follows:

Sec.  60.5411  What additional requirements must I meet to determine
initial compliance for my covers and closed vent systems routing
materials from storage vessels, reciprocating compressors and
centrifugal compressor wet seal degassing systems?

    You must meet the applicable requirements of this section for each
cover and closed vent system used to comply with the emission standards
for your storage vessel, reciprocating compressor or centrifugal
compressor affected facility.
    (a) Closed vent system requirements for reciprocating compressors
and for

centrifugal compressor wet seal degassing systems. (1) You must design
the closed vent system to route all gases, vapors, and fumes emitted
from the material in the reciprocating compressor rod packing emissions
collection system or the wet seal fluid degassing system to a control
device or to a process that meets the requirements specified in Sec.
60.5412(a) through (c).
* * * * *
    (b) * * *
    (3) Each storage vessel thief hatch shall be equipped, maintained
and operated with a weighted mechanism or equivalent, to ensure that
the lid remains properly seated. You must select gasket material for
the hatch based on composition of the fluid in the storage vessel and
weather conditions.
    (c) Closed vent system requirements for storage vessel affected
facilities using a control device or routing emissions to a process.
* * * * *

0
10. Section 60.5412 is amended by revising paragraph (d) introductory
text to read as follows:

Sec.  60.5412  What additional requirements must I meet for determining
initial compliance with control devices used to comply with the
emission standards for my storage vessel or centrifugal compressor
affected facility?

* * * * *
    (d) Each control device used to meet the emission reduction
standard in Sec.  60.5395(d) for your storage vessel affected facility
must be installed according to paragraphs (d)(1) through (3) of this
section, as applicable. As an alternative to paragraph (d)(1) of this
section, you may install a control device model tested under Sec.
60.5413(d), which meets the criteria in Sec.  60.5413(d)(11) and Sec.
60.5413(e).
* * * * *

0
11. Section 60.5413 is amended by:
0
a. Revising the introductory text of paragraph (e); and
0
b. Adding paragraph (e)(7).
    The revision and addition read as follows:

Sec.  60.5413  What are the performance testing procedures for control
devices used to demonstrate compliance at my storage vessel or
centrifugal compressor affected facility?

* * * * *
    (e) Continuous compliance for combustion control devices tested by
the manufacturer in accordance with paragraph (d) of this section. This
paragraph applies to the demonstration of compliance for a combustion
control device tested under the provisions in paragraph (d) of this
section. Owners or operators must demonstrate that a control device
achieves the performance requirements in (d)(11) of this section by
installing a device tested under paragraph (d) of this section and
complying with the criteria specified in paragraphs (e)(1) through (7)
of this section.
* * * * *
    (7) Ensure that each enclosed combustion device is maintained in a
leak free condition.

0
12. Section 60.5415 is amended by:
0
a. Revising paragraph (b)(2) introductory text;
0
b. Revising paragraph (c) introductory text;
0
c. Adding paragraph (c)(4); and
0
d. Removing paragraph (h).
    The revisions and addition read as follows:

Sec.  60.5415  How do I demonstrate continuous compliance with the
standards for my gas well affected facility, my centrifugal compressor
affected facility, my stationary reciprocating compressor affected
facility, my pneumatic controller affected facility, my storage vessel
affected facility, and my affected facilities at onshore natural gas
processing plants?

    (b) * * *
    (2) For each control device used to reduce emissions, you must
demonstrate continuous compliance with the performance requirements of
Sec.  60.5412(a) using the procedures specified in paragraphs (b)(2)(i)
through (vii) of this section. If you use a condenser as the control
device to achieve the requirements specified in Sec.  60.5412(a)(2),
you must demonstrate compliance according to paragraph (b)(2)(viii) of
this section. You may switch between compliance with paragraphs
(b)(2)(i) through (vii) of this section and compliance with paragraph
(b)(2)(viii) of this section only after at least 1 year of operation in
compliance with the selected approach. You must provide notification of
such a change in the compliance method in the next annual report, as
required in Sec.  60.5420(b), following the change.
* * * * *
    (c) For each reciprocating compressor affected facility complying
with Sec.  60.5385(a)(1) or (2), you must demonstrate continuous
compliance according to paragraphs (c)(1) through (3) of this section.
For each reciprocating compressor affected facility complying with
Sec.  60.5385(a)(3), you must demonstrate continuous compliance
according to paragraph (c)(4) of this section.
* * * * *
    (4) You must operate the rod packing emissions collection system
under negative pressure and continuously comply with the closed vent
requirements in Sec.  60.5411(a).
* * * * *

0
13. Section 60.5416 is amended by:
0
a. Revising the section heading;
0
b. Revising the introductory text;
0
c. Revising paragraph (a) introductory text; and
0
d. Revising paragraph (b) introductory text.
    The revisions read as follows:

Sec.  60.5416  What are the initial and continuous cover and closed
vent system inspection and monitoring requirements for my storage
vessel, centrifugal compressor and reciprocating compressor affected
facilities?

    For each closed vent system or cover at your storage vessel,
centrifugal compressor and reciprocating compressor affected facility,
you must comply with the applicable requirements of paragraphs (a)
through (c) of this section.
    (a) Inspections for closed vent systems and covers installed on
each centrifugal compressor or reciprocating compressor affected
facility. Except as provided in paragraphs (b)(11) and (12) of this
section, you must inspect each closed vent system according to the
procedures and schedule specified in paragraphs (a)(1) and (2) of this
section, inspect each cover according to the procedures and schedule
specified in paragraph (a)(3) of this section, and inspect each bypass
device according to the procedures of paragraph (a)(4) of this section.
* * * * *
    (b) No detectable emissions test methods and procedures. If you are
required to conduct an inspection of a closed vent system or cover at
your centrifugal compressor or reciprocating compressor affected
facility as specified in paragraphs (a)(1), (2), or (3) of this
section, you must meet the requirements of paragraphs (b)(1) through
(13) of this section.
* * * * *
0
14. Section 60.5420 is amended by:
0
a. Revising paragraph (b)(1)(iv);
0
b. Revising paragraph (b)(6)(ii);
0
c. Revising paragraphs (b)(6)(vi) and (vii);
0
d. Revising paragraphs (c)(1)(iii)(A) and (B);
0
e. Revising paragraph (c)(3)(ii); and
0
f. Revising paragraphs (c)(7), (8) and (9).
    The revisions read as follows:

Sec.  60.5420  What are my notification, reporting, and recordkeeping
requirements?

* * * * *

    (b) * * *
    (1) * * *
    (iv) A certification by a certifying official of truth, accuracy,
and completeness. This certification shall state that, based on
information and belief formed after reasonable inquiry, the statements
and information in the document are true, accurate, and complete.
* * * * *
    (6) * * *
    (ii) Documentation of the VOC emission rate determination according
to Sec.  60.5365(e) for each storage vessel that became an affected
facility during the reporting period or is returned to service during
the reporting period.
* * * * *
    (vi) You must identify each storage vessel affected facility that
is removed from service during the reporting period as specified in
Sec.  60.5395(f)(1)(ii), including the date the storage vessel affected
facility was removed from service.
    (vii) You must identify each storage vessel affected facility
returned to service during the reporting period as specified in Sec.
60.5395(f)(3), including the date the storage vessel affected facility
was returned to service.
* * * * *
    (c) * * *
    (1) * * *
    (iii) * * *
    (A) For each gas well affected facility required to comply with the
requirements of Sec.  60.5375(a), you must record: The location of the
well; the API well number; the date and time of the onset of flowback
following hydraulic fracturing or refracturing; the date and time of
each attempt to direct flowback to a separator as required in Sec.
60.5375(a)(1)(i); the date and time of each occurrence of returning to
the initial flowback stage under Sec.  60.5375(a)(1)(i); and the date
and time that the well was shut in and the flowback equipment was
permanently disconnected, or the startup of production; the duration of
flowback; duration of recovery to the flow line; duration of
combustion; duration of venting; and specific reasons for venting in
lieu of capture or combustion. The duration must be specified in hours
of time.
    (B) For each gas well affected facility required to comply with the
requirements of Sec.  60.5375(f), you must maintain the records
specified in paragraph (c)(1)(iii)(A) of this section except that you
do not have to record the duration of recovery to the flow line.
* * * * *
    (3) * * *
    (ii) Records of the date and time of each reciprocating compressor
rod packing replacement, or date of installation of a rod packing
emissions collection system and closed vent system as specified in
Sec.  60.5385(a)(3).
* * * * *
    (7) A record of each cover inspection required under Sec.
60.5416(a)(3) for centrifugal or reciprocating compressors or Sec.
60.5416(c)(2) for storage vessels.
    (8) If you are subject to the bypass requirements of Sec.
60.5416(a)(4) for centrifugal or reciprocating compressors or Sec.
60.5416(c)(3) for storage vessels, a record of each inspection or a
record each time the key is checked out or a record of each time the
alarm is sounded.
    (9) If you are subject to the closed vent system no detectable
emissions requirements of Sec.  60.5416(b) for centrifugal or
reciprocating compressors, a record of the monitoring conducted in
accordance with Sec.  60.5416(b).
* * * * *

0
15. Section 60.5430 is amended by:
0
a. Adding, in alphabetical order, definitions for the terms
``Certifying official,'' ``Collection system,'' ``Initial flowback
stage,'' ``Maximum average daily throughput,'' ``Recovered gas,''
``Recovered liquids,'' ``Removed from service,'' ``Returned to
service,'' ``Separation flowback stage,'' ``Startup of production,''
and ``Well completion vessel;''
0
b. Removing the definition of ``Affirmative defense;'' and
0
c. Revising the definitions for ``Equipment'', ``Flowback,'' ``Routed
to a process or route to a process,'' ``Salable quality gas,'' and
``Storage vessel.''
    The revisions read as follows:

Sec.  60.5430  What definitions apply to this subpart?

* * * * *
    Certifying official means one of the following:
    (1) For a corporation: A president, secretary, treasurer, or vice-
president of the corporation in charge of a principal business
function, or any other person who performs similar policy or decision-
making functions for the corporation, or a duly authorized
representative of such person if the representative is responsible for
the overall operation of one or more manufacturing, production, or
operating facilities applying for or subject to a permit and either:
    (i) The facilities employ more than 250 persons or have gross
annual sales or expenditures exceeding $25 million (in second quarter
1980 dollars); or
    (ii) The Administrator is notified of such delegation of authority
prior to the exercise of that authority. The Administrator reserves the
right to evaluate such delegation;
    (2) For a partnership (including but not limited to general
partnerships, limited partnerships, and limited liability partnerships)
or sole proprietorship: A general partner or the proprietor,
respectively. If a general partner is a corporation, the provisions of
paragraph (1) of this definition apply;
    (3) For a municipality, State, Federal, or other public agency:
Either a principal executive officer or ranking elected official. For
the purposes of this part, a principal executive officer of a Federal
agency includes the chief executive officer having responsibility for
the overall operations of a principal geographic unit of the agency
(e.g., a Regional Administrator of EPA); or
    (4) For affected facilities:
    (i) The designated representative in so far as actions, standards,
requirements, or prohibitions under title IV of the Clean Air Act or
the regulations promulgated thereunder are concerned; or
    (ii) The designated representative for any other purposes under
part 60.
* * * * *
    Collection system means any infrastructure that conveys gas or
liquids from the well site to another location for treatment, storage,
processing, recycling, disposal or other handling.
* * * * *
    Equipment, as used in the standards and requirements in this
subpart relative to the equipment leaks of VOC from onshore natural gas
processing plants, means each pump, pressure relief device, open-ended
valve or line, valve, and flange or other connector that is in VOC
service or in wet gas service, and any device or system required by
those same standards and requirements in this subpart.
* * * * *
    Flowback means the process of allowing fluids and entrained solids
to flow from a natural gas well following a treatment, either in
preparation for a subsequent phase of treatment or in preparation for
cleanup and returning the well to production. The term flowback also
means the fluids and entrained solids that emerge from a natural gas
well during the flowback process. The flowback period begins when
material introduced into the well during the treatment returns to the
surface following hydraulic fracturing or refracturing. The flowback
period ends when either the well is shut in and

permanently disconnected from the flowback equipment or at the startup
of production. The flowback period includes the initial flowback stage
and the separation flowback stage.
* * * * *
    Initial flowback stage means the period during a well completion
operation which begins at the onset of flowback and ends at the
separation flowback stage.
* * * * *
    Maximum average daily throughput means the earliest calculation of
daily average throughput during the 30-day PTE evaluation period
employing generally accepted methods.
* * * * *
    Recovered gas means gas recovered through the separation process
during flowback.
    Recovered liquids means any crude oil, condensate or produced water
recovered through the separation process during flowback.
* * * * *
    Removed from service means that a storage vessel affected facility
has been physically isolated and disconnected from the process for a
purpose other than maintenance in accordance with Sec.  60.5395(f)(1).
    Returned to service means that a Group 1 or Group 2 storage vessel
affected facility that was removed from service has been:
    (1) Reconnected to the original source of liquids, connected in
parallel to any storage vessel affected facility or has been used to
replace any storage vessel affected facility; or
    (2) Installed in any location covered by this subpart and
introduced with crude oil, condensate, intermediate hydrocarbon liquids
or produced water.
    Routed to a process or route to a process means the emissions are
conveyed via a closed vent system to any enclosed portion of a process
where the emissions are predominantly recycled and/or consumed in the
same manner as a material that fulfills the same function in the
process and/or transformed by chemical reaction into materials that are
not regulated materials and/or incorporated into a product; and/or
recovered.
    Salable quality gas means natural gas that meets the flow line or
collection system operator specifications, regardless of whether such
gas is sold.
    Separation flowback stage means the period during a well completion
operation when it is technically feasible for a separator to function.
The separation flowback stage ends either at the startup of production,
or when the well is shut in and permanently disconnected from the
flowback equipment.
    Startup of production means the beginning of initial flow following
the end of flowback when there is continuous recovery of salable
quality gas and separation and recovery of any crude oil, condensate or
produced water.
    Storage vessel means a tank or other vessel that contains an
accumulation of crude oil, condensate, intermediate hydrocarbon
liquids, or produced water, and that is constructed primarily of
nonearthen materials (such as wood, concrete, steel, fiberglass, or
plastic) which provide structural support. Two or more storage vessels
connected in parallel are considered equivalent to a single storage
vessel with throughput equal to the total throughput of the storage
vessels connected in parallel. A well completion vessel that receives
recovered liquids from a well after startup of production following
flowback for a period which exceeds 60 days is considered a storage
vessel under this subpart. A tank or other vessel shall not be
considered a storage vessel if it has been removed from service in
accordance with the requirements of Sec.  60.5395(f) until such time as
such tank or other vessel has been returned to service. For the
purposes of this subpart, the following are not considered storage
vessels:
    (1) Vessels that are skid-mounted or permanently attached to
something that is mobile (such as trucks, railcars, barges or ships),
and are intended to be located at a site for less than 180 consecutive
days. If you do not keep or are not able to produce records, as
required by Sec.  60.5420(c)(5)(iv), showing that the vessel has been
located at a site for less than 180 consecutive days, the vessel
described herein is considered to be a storage vessel from the date the
original vessel was first located at the site. This exclusion does not
apply to a well completion vessel as described above.
    (2) Process vessels such as surge control vessels, bottoms
receivers or knockout vessels.
    (3) Pressure vessels designed to operate in excess of 204.9
kilopascals and without emissions to the atmosphere.
* * * * *
    Well completion vessel means a vessel that contains flowback during
a well completion operation following hydraulic fracturing or
refracturing. A well completion vessel may be a lined earthen pit, a
tank or other vessel that is skid-mounted or portable. A well
completion vessel that receives recovered liquids from a well after
startup of production following flowback for a period which exceeds 60
days is considered a storage vessel under this subpart.
* * * * *
[FR Doc. 2014-30630 Filed 12-30-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 28, 2006 (Volume 71, Number 249)]
[Notices]
[Page 78186-78187]
[DOCID:fr28de06-65]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2301-022]

PPL Montana; Notice of Teleconference to Discuss Additional
Information Needs for the Mystic Lake Hydroelectric Project

December 20, 2006.
    a. Date and Time of Teleconference: January 8, 2007; 9 a.m. MST (11
a.m. EST).

    b. Teleconference Call: Call-in procedures and an agenda will be
posted to the Commission's Web site soon at: http://www.ferc.gov/EventCalendar/EventsList.aspx?Date=1/6/2007&CalendarID=0
.

    c. FERC Contact: Steve Hocking at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    d. Purpose of Teleconference: PPL Montana filed an application to
relicense the Mystic Lake Hydroelectric Project on December 15, 2006.
Commission staff may include a ``Wilderness Avoidance Alternative'' in
our NEPA analysis to analyze lowered lake levels in both Mystic and
West Rosebud Lakes, if needed, to prevent these two lakes from
encroaching upon the Absaroka-Beartooth Wilderness Area. This
teleconference is to help Commission staff determine whether any
additional information is needed to analyze a ``Wilderness Avoidance
Alternative'' in our NEPA document.

Magalie R. Salas,
Secretary.
[FR Doc. E6-22228 Filed 12-27-06; 8:45 am]

BILLING CODE 6717-01-P