described in paragraph (d)(1) of this section.

0
14. Section 314.97 is revised to read as follows:

Sec.  314.97  Supplements and other changes to an approved ANDA.

    (a) General requirements. The applicant must comply with the
requirements of Sec. Sec.  314.70 and 314.71 regarding the submission
of supplemental ANDAs and other changes to an approved ANDA.
    (b) Different listed drug. An applicant may not supplement an ANDA
to seek approval of a drug referring to a listed drug that is different
from the current reference listed drug identified in the ANDA. This
paragraph (b) applies if changes are proposed in a supplement to the
ANDA such that the proposed product is a pharmaceutical equivalent to a
different listed drug than the reference listed drug identified in the
ANDA. A change of reference listed drug must be submitted in a new
ANDA. However, notwithstanding the limitation described in this
paragraph (b), an applicant may supplement the ANDA to seek approval of
a different strength.

0
15. Section 314.99 is revised to read as follows:

Sec.  314.99  Other responsibilities of an applicant of an ANDA.

    (a) An applicant must comply with the requirements of Sec.  314.65
regarding withdrawal by the applicant of an unapproved ANDA and Sec.
314.72 regarding a change in ownership of an ANDA.
    (b) An applicant may ask FDA to waive under this section any
requirement that applies to the applicant under Sec. Sec.  314.92
through 314.99. The applicant must comply with the requirements for a
waiver under Sec.  314.90. If FDA grants the applicant's waiver request
with respect to a requirement under Sec. Sec.  314.92 through 314.99,
the waived requirement will not constitute a basis for refusal to
approve an ANDA under Sec.  314.127.

0
16. Section 314.101 is revised to read as follows:

Sec.  314.101  Filing an NDA and receiving an ANDA.

    (a) Filing an NDA. (1) Within 60 days after FDA receives an NDA,
the Agency will determine whether the NDA may be filed. The filing of
an NDA means that FDA has made a threshold determination that the NDA
is sufficiently complete to permit a substantive review.
    (2) If FDA finds that none of the reasons in paragraphs (d) and (e)
of this section for refusing to file the NDA apply, the Agency will
file the NDA and notify the applicant in writing. In the case of a
505(b)(2) application that contains a paragraph IV certification, the
applicant will be notified via a paragraph IV acknowledgment letter.
The date of filing will be the date 60 days after the date FDA received
the NDA. The date of filing begins the 180-day period described in
section 505(c) of the Federal Food, Drug, and Cosmetic Act. This 180-
day period is called the ``filing clock.''
    (3) If FDA refuses to file the NDA, the Agency will notify the
applicant in writing and state the reason under paragraph (d) or (e) of
this section for the refusal. If FDA refuses to file the NDA under
paragraph (d) of this section, the applicant may request in writing
within 30 days of the date of the Agency's notification an informal
conference with the Agency about whether the Agency should file the
NDA. If, following the informal conference, the applicant requests that
FDA file the NDA (with or without amendments to correct the
deficiencies), the Agency will file the NDA over protest under
paragraph (a)(2) of this section, notify the applicant in writing, and
review it as filed. If the NDA is filed over protest, the date of
filing will be the date 60 days after the date the applicant requested
the informal conference. The applicant need not resubmit a copy of an
NDA that is filed over protest. If FDA refuses to file the NDA under
paragraph (e) of this section, the applicant may amend the NDA and
resubmit it, and the Agency will make a determination under this
section whether it may be filed.
    (b)(1) Receiving an ANDA. An ANDA will be evaluated after it is
submitted to determine whether the ANDA may be received. Receipt of an
ANDA means that FDA has made a threshold determination that the
abbreviated application is substantially complete.
    (2) If FDA finds that none of the reasons in paragraphs (d) and (e)
of this section for considering the ANDA not to have been received
applies, the ANDA is substantially complete and the Agency will receive
the ANDA and notify the applicant in writing. If FDA determines, upon
evaluation, that an ANDA was substantially complete as of the date it
was submitted to FDA, FDA will consider the ANDA to have been received
as of the date of submission. In the case of an ANDA that contains a
paragraph IV certification, the applicant will be notified via a
paragraph IV acknowledgment letter.
    (3) If FDA considers the ANDA not to have been received under
paragraph (d) or (e) of this section, FDA will notify the applicant of
the refuse-to-receive decision. The applicant may then:
    (i) Withdraw the ANDA under Sec.  314.99; or
    (ii) Correct the deficiencies and resubmit the ANDA; or
    (iii) Take no action, in which case FDA may consider the ANDA
withdrawn after 1 year.

    (c) [Reserved]
    (d) NDA or ANDA deficiencies. FDA may refuse to file an NDA or may
not consider an ANDA to be received if any of the following applies:
    (1) The NDA or ANDA does not contain a completed application form.
    (2) The NDA or ANDA is not submitted in the form required under
Sec.  314.50 or Sec.  314.94.
    (3) The NDA or ANDA is incomplete because it does not on its face
contain information required under section 505(b) or section 505(j) of
the Federal Food, Drug, and Cosmetic Act and Sec.  314.50 or Sec.
314.94. In determining whether an ANDA is incomplete on its face, FDA
will consider the nature (e.g., major or minor) of the deficiencies,
including the number of deficiencies in the ANDA.
    (4) The applicant fails to submit a complete environmental
assessment, which addresses each of the items specified in the
applicable format under Sec.  25.40 of this chapter or fails to provide
sufficient information to establish that the requested action is
subject to categorical exclusion under Sec.  25.30 or Sec.  25.31 of
this chapter.
    (5) The NDA or ANDA does not contain an accurate and complete
English translation of each part of the NDA or ANDA that is not in
English.
    (6) The NDA or ANDA does not contain a statement for each
nonclinical laboratory study that the study was conducted in compliance
with the requirements set forth in part 58 of this chapter, or, for
each study not conducted in compliance with part 58 of this chapter, a
brief statement of the reason for the noncompliance.
    (7) The NDA or ANDA does not contain a statement for each clinical
study that the study was conducted in compliance with the institutional
review board regulations in part 56 of this chapter, or was not subject
to those regulations, and that it was conducted in compliance with the
informed consent regulations in part 50 of this chapter, or, if the
study was subject to but was not conducted in compliance with those
regulations, the NDA or ANDA does not contain a brief statement of the
reason for the noncompliance.
    (8) The drug product that is the subject of the submission is
already covered by an approved NDA or ANDA and the applicant of the
submission:
    (i) Has an approved NDA or ANDA for the same drug product; or
    (ii) Is merely a distributor and/or repackager of the already
approved drug product.
    (9) The NDA is submitted as a 505(b)(2) application for a drug that
is a duplicate of a listed drug and is eligible for approval under
section 505(j) of the Federal Food, Drug, and Cosmetic Act.
    (e) Regulatory deficiencies. The Agency will refuse to file an NDA
or will consider an ANDA not to have been received if any of the
following applies:
    (1) The drug product is subject to licensing by FDA under the
Public Health Service Act (42 U.S.C. 201 et seq.) and subchapter F of
this chapter.
    (2) Submission of a 505(b)(2) application or an ANDA is not
permitted under section 505(c)(3)(E)(ii), 505(j)(5)(F)(ii),
505A(b)(1)(A)(i)(I), 505A(c)(1)(A)(i)(I), or 505E(a) of the Federal
Food, Drug, and Cosmetic Act.
    (f) Outcome of FDA review. (1) Within 180 days after the date of
filing, plus the period of time the review period was extended (if
any), FDA will either:
    (i) Approve the NDA; or
    (ii) Issue a notice of opportunity for a hearing if the applicant
asked FDA to provide it an opportunity for a hearing on an NDA in
response to a complete response letter.
    (2) Within 180 days after the date of receipt, plus the period of
time the review clock was extended (if any), FDA will either approve or
disapprove the ANDA. If FDA disapproves the ANDA, FDA will issue a
notice of opportunity for hearing if the applicant asked FDA to provide
it an opportunity for a hearing on an ANDA in response to a complete
response letter.
    (3) This paragraph (f) does not apply to NDAs or ANDAs that have
been withdrawn from FDA review by the applicant.

0
17. Section 314.105 is revised to read as follows:

Sec.  314.105  Approval of an NDA and an ANDA.

    (a) FDA will approve an NDA and send the applicant an approval
letter if none of the reasons in Sec.  314.125 for refusing to approve
the NDA applies. FDA will issue a tentative approval letter if an NDA
otherwise meets the requirements for approval under the Federal Food,
Drug, and Cosmetic Act, but cannot be approved because there is a 7-
year period of orphan exclusivity for the listed drug under section 527
of the Federal Food, Drug, and Cosmetic Act and Sec.  316.31 of this
chapter, or if a 505(b)(2) application otherwise meets the requirements
for approval under the Federal Food, Drug, and Cosmetic Act, but cannot
be approved until the conditions in Sec.  314.107(b)(3) are met;
because there is a period of exclusivity for the listed drug under
Sec.  314.108; because there is a period of pediatric exclusivity for
the listed drug under section 505A of the Federal Food, Drug, and
Cosmetic Act; or because there is a period of exclusivity for the
listed drug under section 505E of the Federal Food, Drug, and Cosmetic
Act. A drug product that is granted tentative approval is not an
approved drug and will not be approved until FDA issues an approval
after any necessary additional review of the NDA. FDA's tentative
approval of a drug product is based on information available to FDA at
the time of the tentative approval letter (i.e., information in the
505(b)(2) application and the status of current good manufacturing
practices of the facilities used in the manufacturing and testing of
the drug product) and is therefore subject to change on the basis of
new information that may come to FDA's attention. A new drug product
may not be marketed until the date of approval.
    (b) FDA will approve an NDA and issue the applicant an approval
letter on the basis of draft labeling if the only deficiencies in the
NDA concern editorial or similar minor deficiencies in the draft
labeling. Such approval will be conditioned upon the applicant
incorporating the specified labeling changes exactly as directed, and
upon the applicant submitting to FDA a copy of the final printed
labeling prior to marketing.
    (c) FDA will approve an NDA after it determines that the drug meets
the statutory standards for safety and effectiveness, manufacturing and
controls, and labeling, and an ANDA after it determines that the drug
meets the statutory standards for manufacturing and controls, labeling,
and, where applicable, bioequivalence. While the statutory standards
apply to all drugs, the many kinds of drugs that are subject to the
statutory standards and the wide range of uses for those drugs demand
flexibility in applying the standards. Thus FDA is required to exercise
its scientific judgment to determine the kind and quantity of data and
information an applicant is required to provide for a particular drug
to meet the statutory standards. FDA makes its views on drug products
and classes of drugs available through guidance documents,
recommendations, and other statements of policy.
    (d) FDA will approve an ANDA and send the applicant an approval
letter if none of the reasons in Sec.  314.127 for refusing to approve
the ANDA applies. FDA will issue a tentative approval letter if an ANDA
otherwise meets the requirements for approval under the Federal Food,
Drug, and Cosmetic Act, but cannot be approved because there is a 7-
year period of orphan exclusivity for the listed drug under section 527
of the

Federal Food, Drug, and Cosmetic Act and Sec.  316.31 of this chapter,
or cannot be approved until the conditions in Sec.  314.107(b)(3) or
(c) are met; because there is a period of exclusivity for the listed
drug under Sec.  314.108; because there is a period of pediatric
exclusivity for the listed drug under section 505A of the Federal Food,
Drug, and Cosmetic Act; or because there is a period of exclusivity for
the listed drug under section 505E of the Federal Food, Drug, and
Cosmetic Act. A drug product that is granted tentative approval is not
an approved drug and will not be approved until FDA issues an approval
after any necessary additional review of the ANDA. FDA's tentative
approval of a drug product is based on information available to FDA at
the time of the tentative approval letter (i.e., information in the
ANDA and the status of current good manufacturing practices of the
facilities used in the manufacturing and testing of the drug product)
and is therefore subject to change on the basis of new information that
may come to FDA's attention. A new drug product may not be marketed
until the date of approval.

0
18. Section 314.107 is revised to read as follows:

Sec.  314.107  Date of approval of a 505(b)(2) application or ANDA.

    (a) General. A drug product may be introduced or delivered for
introduction into interstate commerce when the 505(b)(2) application or
ANDA for the drug product is approved. A 505(b)(2) application or ANDA
for a drug product is approved on the date FDA issues an approval
letter under Sec.  314.105 for the 505(b)(2) application or ANDA.
    (b) Effect of patent(s) on the listed drug. As described in
paragraphs (b)(1) and (2) of this section, the status of patents listed
for the listed drug(s) relied upon or reference listed drug, as
applicable, must be considered in determining the first possible date
on which a 505(b)(2) application or ANDA can be approved. The criteria
in paragraphs (b)(1) and (2) of this section will be used to determine,
for each relevant patent, the date that patent will no longer prevent
approval. The first possible date on which the 505(b)(2) application or
ANDA can be approved will be calculated for each patent, and the
505(b)(2) application or ANDA may be approved on the last applicable
date.
    (1) Timing of approval based on patent certification or statement.
If none of the reasons in Sec.  314.125 or Sec.  314.127, as
applicable, for refusing to approve the 505(b)(2) application or ANDA
applies, and none of the reasons in paragraph (d) of this section for
delaying approval applies, the 505(b)(2) application or ANDA may be
approved as follows:
    (i) Immediately, if the applicant certifies under Sec.  314.50(i)
or Sec.  314.94(a)(12) that:
    (A) The applicant is aware of a relevant patent but the patent
information required under section 505(b) or (c) of the Federal Food,
Drug, and Cosmetic Act has not been submitted to FDA; or
    (B) The relevant patent has expired; or
    (C) The relevant patent is invalid, unenforceable, or will not be
infringed, except as provided in paragraphs (b)(3) and (c) of this
section, and the 45-day period provided for in section 505(c)(3)(C) and
(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act has expired;
or
    (D) There are no relevant patents.
    (ii) Immediately, if the applicant submits an appropriate statement
under Sec.  314.50(i) or Sec.  314.94(a)(12) explaining that a method-
of-use patent does not claim an indication or other condition of use
for which the applicant is seeking approval, except that if the
applicant also submits a paragraph IV certification to the patent, then
the 505(b)(2) application or ANDA may be approved as provided in
paragraph (b)(1)(i)(C) of this section.
    (iii) On the date specified, if the applicant certifies under Sec.
314.50(i) or Sec.  314.94(a)(12) that the relevant patent will expire
on a specified date.
    (2) Patent information filed after submission of 505(b)(2)
application or ANDA. If the holder of the approved NDA for the listed
drug submits patent information required under Sec.  314.53 after the
date on which the 505(b)(2) application or ANDA was submitted to FDA,
the 505(b)(2) applicant or ANDA applicant must comply with the
requirements of Sec.  314.50(i)(4) and (6) and Sec.  314.94(a)(12)(vi)
and (viii) regarding submission of an appropriate patent certification
or statement. If the applicant submits an amendment certifying under
Sec.  314.50(i)(1)(i)(A)(4) or Sec.  314.94(a)(12)(i)(A)(4) that the
relevant patent is invalid, unenforceable, or will not be infringed,
and complies with the requirements of Sec.  314.52 or Sec.  314.95, the
505(b)(2) application or ANDA may be approved immediately upon
submission of documentation of receipt of notice of paragraph IV
certification under Sec.  314.52(e) or Sec.  314.95(e). The 45-day
period provided for in section 505(c)(3)(C) and (j)(5)(B)(iii) of the
Federal Food, Drug, and Cosmetic Act does not apply in these
circumstances.
    (3) Disposition of patent litigation--(i) Approval upon expiration
of 30-month period or 7\1/2\ years from date of listed drug approval.
(A) Except as provided in paragraphs (b)(3)(ii) through (viii) of this
section, if, with respect to patents for which required information was
submitted under Sec.  314.53 before the date on which the 505(b)(2)
application or ANDA was submitted to FDA (excluding an amendment or
supplement to the 505(b)(2) application or ANDA), the applicant
certifies under Sec.  314.50(i) or Sec.  314.94(a)(12) that the
relevant patent is invalid, unenforceable, or will not be infringed,
and the patent owner or its representative or the exclusive patent
licensee brings suit for patent infringement within 45 days of receipt
of the notice of certification from the applicant under Sec.  314.52 or
Sec.  314.95, the 505(b)(2) application or ANDA may be approved 30
months after the later of the date of the receipt of the notice of
certification by any owner of the listed patent or by the NDA holder
(or its representative(s)) unless the court has extended or reduced the
period because of a failure of either the plaintiff or defendant to
cooperate reasonably in expediting the action; or
    (B) If the patented drug product qualifies for 5 years of exclusive
marketing under Sec.  314.108(b)(2) and the patent owner or its
representative or the exclusive patent licensee brings suit for patent
infringement during the 1-year period beginning 4 years after the date
of approval of the patented drug and within 45 days of receipt of the
notice of certification from the applicant under Sec.  314.52 or Sec.
314.95, the 505(b)(2) application or ANDA may be approved at the
expiration of the 7\1/2\ years from the date of approval of the NDA for
the patented drug product.
    (ii) Federal district court decision of invalidity,
unenforceability, or non-infringement. If before the expiration of the
30-month period, or 7\1/2\ years where applicable, the district court
decides that the patent is invalid, unenforceable, or not infringed
(including any substantive determination that there is no cause of
action for patent infringement or invalidity), the 505(b)(2)
application or ANDA may be approved on:
    (A) The date on which the court enters judgment reflecting the
decision; or
    (B) The date of a settlement order or consent decree signed and
entered by the court stating that the patent that is the subject of the
certification is invalid, unenforceable, or not infringed.
    (iii) Appeal of Federal district court judgment of infringement. If
before the expiration of the 30-month period, or 7\1/2\ years where
applicable, the district court decides that the patent has been

infringed, and if the judgment of the district court is appealed, the
505(b)(2) application or ANDA may be approved on:
    (A) The date on which the mandate is issued by the court of appeals
entering judgment that the patent is invalid, unenforceable, or not
infringed (including any substantive determination that there is no
cause of action for patent infringement or invalidity); or
    (B) The date of a settlement order or consent decree signed and
entered by the court of appeals stating that the patent that is the
subject of the certification is invalid, unenforceable, or not
infringed.
    (iv) Affirmation or non-appeal of Federal district court judgment
of infringement. If before the expiration of the 30-month period, or
7\1/2\ years where applicable, the district court decides that the
patent has been infringed, and if the judgment of the district court is
not appealed or is affirmed, the 505(b)(2) application or ANDA may be
approved no earlier than the date specified by the district court in an
order under 35 U.S.C. 271(e)(4)(A).
    (v) Grant of preliminary injunction by Federal district court. If
before the expiration of the 30-month period, or 7\1/2\ years where
applicable, the district court grants a preliminary injunction
prohibiting the applicant from engaging in the commercial manufacture
or sale of the drug product until the court decides the issues of
patent validity and infringement, and if the court later decides that:
    (A) The patent is invalid, unenforceable, or not infringed, the
505(b)(2) application or ANDA may be approved as provided in paragraph
(b)(3)(ii) of this section; or
    (B) The patent is infringed, the 505(b)(2) application or ANDA may
be approved as provided in paragraph (b)(3)(iii) or (iv) of this
section, whichever is applicable.
    (vi) Written consent to approval by patent owner or exclusive
patent licensee. If before the expiration of the 30-month period, or
7\1/2\ years where applicable, the patent owner or the exclusive patent
licensee (or their representatives) agrees in writing that the
505(b)(2) application or ANDA may be approved any time on or after the
date of the consent, approval may be granted on or after that date.
    (vii) Court order terminating 30-month or 7\1/2\-year period. If
before the expiration of the 30-month period, or 7\1/2\ years where
applicable, the court enters an order requiring the 30-month or 7\1/2\-
year period to be terminated, the 505(b)(2) application or ANDA may be
approved in accordance with the court's order.
    (viii) Court order of dismissal without a finding of infringement.
If before the expiration of the 30-month period, or 7\1/2\ years where
applicable, the court(s) enter(s) an order of dismissal, with or
without prejudice, without a finding of infringement in each pending
suit for patent infringement brought within 45 days of receipt of the
notice of paragraph IV certification sent by the 505(b)(2) or ANDA
applicant, the 505(b)(2) application or ANDA may be approved on or
after the date of the order.
    (4) Tentative approval. FDA will issue a tentative approval letter
when tentative approval is appropriate in accordance with this section.
In order for a 505(b)(2) application or ANDA to be approved under
paragraph (b)(3) of this section, the applicant must receive an
approval letter from the Agency. Tentative approval of an NDA or ANDA
does not constitute ``approval'' of an NDA or ANDA and cannot, absent
an approval letter from the Agency, result in an approval under
paragraph (b)(3) of this section.
    (c) Timing of approval of subsequent ANDA. (1) If an ANDA contains
a paragraph IV certification for a relevant patent and the ANDA is not
that of a first applicant, the ANDA is regarded as the ANDA of a
subsequent applicant. The ANDA of a subsequent applicant will not be
approved during the period when any first applicant is eligible for
180-day exclusivity or during the 180-day exclusivity period of a first
applicant. Any applicable 180-day exclusivity period cannot extend
beyond the expiration of the patent upon which the 180-day exclusivity
period was based.
    (2) A first applicant must submit correspondence to its ANDA
notifying FDA within 30 days of the date of its first commercial
marketing of its drug product or the reference listed drug. If an
applicant does not notify FDA, as required in this paragraph (c)(2), of
this date, the date of first commercial marketing will be deemed to be
the date of the drug product's approval.
    (3) If FDA concludes that a first applicant is not actively
pursuing approval of its ANDA, FDA may immediately approve an ANDA(s)
of a subsequent applicant(s) if the ANDA(s) is otherwise eligible for
approval.
    (d) Delay due to exclusivity. The Agency will also delay the
approval of a 505(b)(2) application or ANDA if delay is required by the
exclusivity provisions in Sec.  314.108; section 527 of the Federal
Food, Drug, and Cosmetic Act and Sec.  316.31 of this chapter; section
505A of the Federal Food, Drug, and Cosmetic Act; or section 505E of
the Federal Food, Drug, and Cosmetic Act. When the approval of a
505(b)(2) application or ANDA is delayed under this section and Sec.
314.108; section 527 of the Federal Food, Drug, and Cosmetic Act and
Sec.  316.31 of this chapter; section 505A of the Federal Food, Drug,
and Cosmetic Act; or section 505E of the Federal Food, Drug, and
Cosmetic Act, the 505(b)(2) application or ANDA will be approved on the
latest of the days specified under this section and Sec.  314.108;
section 527 of the Federal Food, Drug, and Cosmetic Act and Sec.
316.31 of this chapter; section 505A of the Federal Food, Drug, and
Cosmetic Act; or section 505E of the Federal Food, Drug, and Cosmetic
Act, as applicable.
    (e) Notification of court actions or written consent to approval.
(1) The applicant must submit the following information to FDA, as
applicable:
    (i) A copy of any judgment by the court (district court or mandate
of the court of appeals) or settlement order or consent decree signed
and entered by the court (district court or court of appeals) finding a
patent described in paragraph (b)(3) of this section invalid,
unenforceable, or not infringed, or finding the patent valid and
infringed;
    (ii) Written notification of whether or not any action by the court
described in paragraph (e)(1)(i) of this section has been appealed
within the time permitted for an appeal;
    (iii) A copy of any order entered by the court terminating the 30-
month or 7\1/2\-year period as described in paragraph (b)(3)(i), (ii),
(vii), or (viii) of this section;
    (iv) A copy of any written consent to approval by the patent owner
or exclusive patent licensee described in paragraph (b)(3)(vi) of this
section;
    (v) A copy of any preliminary injunction described in paragraph
(b)(3)(v) of this section, and a copy of any subsequent court order
lifting the injunction; and
    (vi) A copy of any court order pursuant to 35 U.S.C. 271(e)(4)(A)
ordering that a 505(b)(2) application or ANDA may be approved no
earlier than the date specified (irrespective of whether the injunction
relates to a patent described in paragraph (b)(3) of this section).
    (2) All information required by paragraph (e)(1) of this section
must be sent to the applicant's NDA or ANDA, as appropriate, within 14
days of the date of entry by the court, the date of appeal or
expiration of the time for appeal, or the date of written consent to
approval, as applicable.

    (f) Forty-five day period after receipt of notice of paragraph IV
certification--(1) Computation of 45-day time clock. The 45-day clock
described in paragraph (b)(3) of this section as to each recipient
required to receive notice of paragraph IV certification under Sec.
314.52 or Sec.  314.95 begins on the day after the date of receipt of
the applicant's notice of paragraph IV certification by the recipient.
When the 45th day falls on Saturday, Sunday, or a Federal holiday, the
45th day will be the next day that is not a Saturday, Sunday, or a
Federal holiday.
    (2) Notification of filing of legal action. (i) The 505(b)(2) or
ANDA applicant must notify FDA in writing within 14 days of the filing
of any legal action filed within 45 days of receipt of the notice of
paragraph IV certification by any recipient. A 505(b)(2) applicant must
send the notification to its NDA. An ANDA applicant must send the
notification to its ANDA. The notification to FDA of the legal action
must include:
    (A) The 505(b)(2) application or ANDA number.
    (B) The name of the 505(b)(2) or ANDA applicant.
    (C) The established name of the drug product or, if no established
name exists, the name(s) of the active ingredient(s), the drug
product's strength, and dosage form.
    (D) A statement that an action for patent infringement, identified
by court, case number, and the patent number(s) of the patent(s) at
issue in the action, has been filed in an appropriate court on a
specified date.
    (ii) A patent owner or NDA holder (or its representative(s)) may
also notify FDA of the filing of any legal action for patent
infringement. The notice should contain the information and be sent to
the offices or divisions described in paragraph (f)(2)(i) of this
section.
    (iii) If the 505(b)(2) or ANDA applicant, the patent owner(s), the
NDA holder, or its representative(s) does not notify FDA in writing
before the expiration of the 45-day time period or the completion of
the Agency's review of the 505(b)(2) application or ANDA, whichever
occurs later, that a legal action for patent infringement was filed
within 45 days of receipt of the notice of paragraph IV certification,
the 505(b)(2) application or ANDA may be approved upon expiration of
the 45-day period (if the 505(b)(2) or ANDA applicant confirms that a
legal action for patent infringement has not been filed) or upon
completion of the Agency's review of the 505(b)(2) application or ANDA,
whichever is later.
    (3) Waiver. If the patent owner or NDA holder who is an exclusive
patent licensee (or its representative(s)) waives its opportunity to
file a legal action for patent infringement within 45 days of a receipt
of the notice of certification and the patent owner or NDA holder who
is an exclusive patent licensee (or its representative(s)) submits to
FDA a valid waiver before the 45 days elapse, the 505(b)(2) application
or ANDA may be approved upon completion of the Agency's review of the
NDA or ANDA. FDA will only accept a waiver in the following form:

    (Name of patent owner or NDA holder who is an exclusive patent
licensee or its representative(s)) has received notice from (name of
applicant) under (section 505(b)(3) or 505(j)(2)(B) of the Federal
Food, Drug, and Cosmetic Act) and does not intend to file an action
for patent infringement against (name of applicant) concerning the
drug (name of drug) before (date on which 45 days elapse). (Name of
patent owner or NDA holder who is an exclusive patent licensee)
waives the opportunity provided by (section 505(c)(3)(C) or
505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act) and
does not object to FDA's approval of (name of applicant)'s
(505(b)(2) application or ANDA) for (name of drug) with an approval
date on or after the date of this submission.

    (g) Conversion of approval to tentative approval. If FDA issues an
approval letter in error or a court enters an order requiring, in the
case of an already approved 505(b)(2) application or ANDA, that the
date of approval be delayed, FDA will convert the approval to a
tentative approval if appropriate.

0
19. Amend Sec.  314.108 as follows:
0
a. In paragraph (a):
0
i. Revise the introductory text and the definitions of ``Approved under
section 505(b)'', ``Essential to approval'', and ``New chemical
entity'';
0
ii. Remove the definitions of ``Active moiety'', ``Date of approval'',
and ``FDA''; and
0
iii. Add in alphabetical order the definition of ``Bioavailability
study''; and
0
b. Revise the paragraph (b) heading and paragraphs (b)(2) through (5).
    The revisions and addition read as follows:

Sec.  314.108  New drug product exclusivity.

    (a) Definitions. The definitions in Sec.  314.3 and the following
definitions of terms apply to this section:
    Approved under section 505(b) means an NDA submitted under section
505(b) and approved on or after October 10, 1962, or an application
that was ``deemed approved'' under section 107(c)(2) of Public Law 87-
781.
    Bioavailability study means a study to determine the
bioavailability or the pharmacokinetics of a drug.
* * * * *
    Essential to approval means, with regard to an investigation, that
there are no other data available that could support approval of the
NDA.
    New chemical entity means a drug that contains no active moiety
that has been approved by FDA in any other NDA submitted under section
505(b) of the Federal Food, Drug, and Cosmetic Act.
* * * * *
    (b) Submission of and timing of approval of a 505(b)(2) application
or ANDA. * * *
    (2) If a drug product that contains a new chemical entity was
approved after September 24, 1984, in an NDA submitted under section
505(b) of the Federal Food, Drug, and Cosmetic Act, no person may
submit a 505(b)(2) application or ANDA under section 505(j) of the
Federal Food, Drug, and Cosmetic Act for a drug product that contains
the same active moiety as in the new chemical entity for a period of 5
years from the date of approval of the first approved NDA, except that
the 505(b)(2) application or ANDA may be submitted after 4 years if it
contains a certification of patent invalidity or noninfringement
described in Sec.  314.50(i)(1)(i)(A)(4) or Sec.
314.94(a)(12)(i)(A)(4).
    (3) The approval of a 505(b)(2) application or ANDA described in
paragraph (b)(2) of this section will occur as provided in Sec.
314.107(b)(1) or (2), unless the owner of a patent that claims the
drug, the patent owner's representative, or exclusive licensee brings
suit for patent infringement against the applicant during the 1-year
period beginning 48 months after the date of approval of the NDA for
the new chemical entity and within 45 days after receipt of the notice
described at Sec.  314.52 or Sec.  314.95, in which case, approval of
the 505(b)(2) application or ANDA will occur as provided in Sec.
314.107(b)(3).
    (4) If an NDA:
    (i) Was submitted under section 505(b) of the Federal Food, Drug,
and Cosmetic Act;
    (ii) Was approved after September 24, 1984;
    (iii) Was for a drug product that contains an active moiety that
has been previously approved in another NDA under section 505(b) of the
Federal Food, Drug, and Cosmetic Act; and
    (iv) Contained reports of new clinical investigations (other than
bioavailability studies) conducted or sponsored by the

applicant that were essential to approval of the application, for a
period of 3 years after the date of approval of the application, the
Agency will not approve a 505(b)(2) application or an ANDA for the
conditions of approval of the NDA, or an ANDA submitted pursuant to an
approved petition under section 505(j)(2)(C) of the Federal Food, Drug,
and Cosmetic Act that relies on the information supporting the
conditions of approval of an original NDA.
    (5) If a supplemental NDA:
    (i) Was approved after September 24, 1984; and
    (ii) Contained reports of new clinical investigations (other than
bioavailability studies) that were conducted or sponsored by the
applicant that were essential to approval of the supplemental NDA, for
a period of 3 years after the date of approval of the supplemental
application, the Agency will not approve a 505(b)(2) application or an
ANDA for a change, or an ANDA submitted pursuant to an approved
petition under section 505(j)(2)(C) of the Federal Food, Drug, and
Cosmetic Act that relies on the information supporting a change
approved in the supplemental NDA.

0
20. Amend Sec.  314.125 as follows:
0
a. Remove the word ``application'' and add in its place ``NDA''
wherever it appears in paragraphs (a) introductory text, (a)(2),
(b)(7), (9), (10), and (12), and (b)(14) through (18);
0
b. Remove the word ``act'' and add in its place ``Federal Food, Drug,
and Cosmetic Act'' in paragraphs (a) introductory text and (b)(2),
(11), and (18);
0
c. Revise the section heading and paragraph (b) introductory text; and
0
d. Add paragraph (b)(19).
    The revisions and addition read as follows:

Sec.  314.125  Refusal to approve an NDA.

* * * * *
    (b) FDA may refuse to approve an NDA for any of the following
reasons, unless the requirement has been waived under Sec.  314.90:
* * * * *
    (19) The 505(b)(2) application failed to contain a patent
certification or statement with respect to each listed patent for a
drug product approved in an NDA that:
    (i) Is pharmaceutically equivalent to the drug product for which
the original 505(b)(2) application is submitted; and
    (ii) Was approved before the original 505(b)(2) application was
submitted.
* * * * *

0
21. Amend Sec.  314.127 as follows:
0
a. Remove the words ``abbreviated application'' and ``abbreviated new
drug application'' wherever they appear and add in their place ``ANDA''
in paragraphs (a) introductory text, (a)(3) through (7), (a)(8)(ii)(A)
introductory text, (a)(9) and (10), and (b);
0
b. Remove the word ``act'' wherever it appears and add in its place
``Federal Food, Drug, and Cosmetic Act'' in paragraphs
(a)(3)(iii)(A)(2) and (a)(12);
0
c. Remove ``officer of employee'' and add in its place ``officer or
employee'' in paragraph (b);
0
d. Revise the section heading and paragraphs (a) introductory text,
(a)(2), (a)(8)(i) introductory text, and (a)(8)(ii)(B) and (C); and
0
e. Add paragraph (a)(14).
    The revisions and addition read as follows:

Sec.  314.127  Refusal to approve an ANDA.

    (a) FDA will refuse to approve an ANDA for a new drug under section
505(j) of the Federal Food, Drug, and Cosmetic Act for any of the
following reasons, unless the requirement has been waived under Sec.
314.99:
* * * * *
    (2) Information submitted with the ANDA is insufficient to show
that each of the proposed conditions of use has been previously
approved for the listed drug referred to in the ANDA.
* * * * *
    (8)(i) Information submitted in the ANDA or any other information
available to FDA shows that:
* * * * *
    (ii) * * *
    (B) FDA will consider an inactive ingredient in, or the composition
of, a drug product intended for parenteral use to be unsafe and will
refuse to approve the ANDA unless it contains the same inactive
ingredients, other than preservatives, buffers, and antioxidants, in
the same concentration as the listed drug, and, if it differs from the
listed drug in a preservative, buffer, or antioxidant, the ANDA
contains sufficient information to demonstrate that the difference does
not affect the safety or efficacy of the drug product.
    (C) FDA will consider an inactive ingredient in, or the composition
of, a drug product intended for ophthalmic or otic use unsafe and will
refuse to approve the ANDA unless it contains the same inactive
ingredients, other than preservatives, buffers, substances to adjust
tonicity, or thickening agents, in the same concentration as the listed
drug, and if it differs from the listed drug in a preservative, buffer,
substance to adjust tonicity, or thickening agent, the ANDA contains
sufficient information to demonstrate that the difference does not
affect the safety or efficacy of the drug product and the labeling does
not claim any therapeutic advantage over or difference from the listed
drug.
* * * * *
    (14) For an ANDA submitted pursuant to an approved petition under
Sec.  10.30 of this chapter and Sec.  314.93, an NDA subsequently has
been approved for the change described in the approved petition.
* * * * *

PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

0
22. The authority citation for part 320 continues to read as follows:

    Authority: 21 U.S.C. 321, 351, 352, 355, 371.

0
23. Section 320.1 is revised to read as follows:

Sec.  320.1  Definitions.

    The definitions contained in Sec.  314.3 of this chapter apply to
those terms when used in this part.

0
24. Amend Sec.  320.23 as follows:
0
a. Revise the last sentence in paragraph (a)(1);
0
b. Remove the word ``shall'' and add in its place the word ``must'' in
paragraph (a)(2);
0
c. Redesignate paragraph (b) as paragraph (b)(1); and
0
d. Add paragraph (b)(2).
    The revisions and additions read as follows:

Sec.  320.23  Basis for measuring in vivo bioavailability or
demonstrating bioequivalence.

    (a)(1) * * * For drug products that are not intended to be absorbed
into the bloodstream, bioavailability may be assessed by scientifically
valid measurements intended to reflect the rate and extent to which the
active ingredient or active moiety becomes available at the site of
action.
* * * * *
    (b) * * *
    (2) For drug products that are not intended to be absorbed into the
bloodstream, bioequivalence may be demonstrated by scientifically valid
methods that are expected to detect a significant difference between
the drug and the listed drug in safety and therapeutic effect.

    Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22690 Filed 10-5-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 9, 2007 (Volume 72, Number 194)]
[Proposed Rules]
[Page 57258-57260]
[DOCID:fr09oc07-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-RO5-RCRA-2007-0722; FRL-8478-4]

Michigan: Final Authorization of State Hazardous Waste Management
Program Revision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Michigan has applied to EPA for final authorization of the
changes to its hazardous waste program under the Resource Conservation
and Recovery Act (RCRA). EPA has reviewed Michigan's application and
has preliminarily determined that these changes satisfy all
requirements needed to qualify for final authorization, and is
proposing to authorize the State's changes.

DATES: Comments on this proposed rule must be received on or before
November 8, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
RCRA-2007-0722 by one of the following methods:
    http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    E-mail<EMAIL_ADDRESS>    Mail: Ms. Judith Feigler, Michigan Regulatory Specialist, RCRA
Programs Section, Land and Chemicals Division, U.S. Environmental
Protection Agency, 77 West Jackson Blvd., Chicago, Illinois 60604.
    Instructions: Direct your comments to Docket ID Number EPA-R05-
RCRA-2007-0722. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal

information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters or any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epagov/epahome/dockets.htm
.

    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some of the

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy. You may view and copy

Michigan's application from 9 a.m. to 4 p.m. at the following
addresses: U.S. EPA Region 5, 77 West Jackson Blvd., Chicago, Illinois,
contact: Judith Feigler<PHONE_NUMBER>; or Michigan Department of
Environmental Quality, Constitution Hall, 525 W. Allegan St., Lansing,
Michigan (mailing address P.O. Box 30241, Lansing, Michigan 48909),
contact Ronda Blayer<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ms. Judith Feigler, Michigan
Regulatory Specialist, RCRA Programs Section, Land and Chemicals
Division, U.S. Environmental Protection Agency, 77 West Jackson Blvd.,
Chicago, Illinois 60604,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. Why Are Revisions to State Programs Necessary?

    States which have received final authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste
program that is equivalent to, consistent with, and no less stringent
than the federal program. As the federal program changes, states must
change their programs and ask EPA to authorize the changes. Changes to
state programs may be necessary when federal or state statutory or
regulatory authority is modified or when certain other changes occur.
Most commonly, states must change their programs because of changes to
EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124,
260 through 266, 268, 270, 273 and 279.

B. What Decisions Have We Made in This Rule?

    We have preliminarily determined that Michigan's application to
revise its authorized program meets all of the statutory and regulatory
requirements established by RCRA. Therefore, we propose to grant
Michigan final authorization to operate its hazardous waste program
with the changes described in the authorization application. Michigan
will have responsibility for permitting treatment, storage, and
disposal facilities (TSDFs) within its borders (except in Indian
Country) and for carrying out the aspects of the RCRA program described
in its revised program application, subject to the limitations of the
Hazardous and Solid Waste Amendments of 1984 (HSWA). New federal
requirements and prohibitions imposed by federal regulations that EPA
promulgates under the authority of HSWA take effect in authorized
states before they are authorized for the requirements. Thus, EPA will
implement those requirements and prohibitions in Michigan, including
issuing permits, until the state is granted authorization to do so.

C. What Will Be the Effect if Michigan Is Authorized for These Changes?

    If Michigan is authorized for these changes, a facility in Michigan
subject to RCRA will have to comply with the authorized state
requirements instead of the equivalent federal requirements in order to
comply with RCRA. Additionally, such persons will have to comply with
any applicable federal requirements, such as HSWA regulations issued by
EPA for which the state has not received authorization, and RCRA
requirements that are not supplanted by authorized state-issued
requirements. Michigan has enforcement responsibilities under its state
hazardous waste program for violations of such program, but EPA retains
its authority under RCRA sections 3007, 3008, 3013, and 7003, which
include, among others, authority to:
    1. Do inspections, and require monitoring, tests, analyses or
reports;

    2. enforce RCRA requirements and suspend or revoke permits; and
    3. take enforcement actions regardless of whether the state has
taken its own actions.
    This proposed action would not impose additional requirements on
the regulated community because the regulations for which Michigan
would be authorized are already effective, and would not be changed by
the act of authorization.

D. What Happens if EPA Receives Comments on This Action?

    If EPA receives comments on this proposed action, we will address
those comments in a later final rule. You may not have another
opportunity to comment. If you want to comment on this authorization,
you must do so at this time.

E. What Has Michigan Previously Been Authorized for?

    Michigan initially received final authorization on October 16,
1986, effective October 30, 1986 (51 FR 36804-36805) to implement the
RCRA hazardous waste management program. We granted authorization for
changes to Michigan's program on November 24, 1989, effective January
23, 1990 (54 FR 48608); on January 24, 1991, effective June 24, 1991
(56 FR 18517); on October 1, 1993, effective November 30, 1993 (58 FR
51244); on January 13, 1995, effective January 13, 1995 (60 FR 3095);
on February 8, 1996, effective April 8, 1996 (61 FR 4742); on November
14, 1997, effective November 14, 1997 (62 FR 61775); on March 2, 1999,
effective June 1, 1999 (64 FR 10111); on July 31, 2002, effective July
31, 2002 (67 FR 49617); and on March 9, 2006, effective March 9, 2006
(71 FR 12141).

F. What Changes Are We Proposing?

    On May 21, 2007, Michigan submitted a complete program revision
application seeking authorization of its changes in accordance with 40
CFR 271.21. We have preliminarily determined that Michigan's hazardous
waste management program revision satisfies all requirements necessary
to qualify for final authorization. Therefore, we propose to grant
Michigan final authorization for the following program changes:

----------------------------------------------------------------------------------------------------------------
                                           Revision
  Description of Federal  requirement     checklist    Federal Register date and     Analogous state authority
                                             \1\                 page
----------------------------------------------------------------------------------------------------------------
Mineral Processing Secondary Materials          167D  May 26, 1998, 63 FR 28556.  Michigan Administrative Code,
 Exclusion.                                                                        R 299.9202(1)(b)(iii) and R
                                                                                299.9204(1)(v), effective
                                                                                December 16, 2004
NESHAP: Surface Coating of Automobiles           205  April 26, 2004, 69 FR       Michigan Combined Laws,
 and Light-Duty Trucks.                                22601.                      324.11105a(1) and (2),
                                                                                effective December 29,
                                                                                2006.\2\
----------------------------------------------------------------------------------------------------------------
\1\ Revision Checklists generally reflect changes made to the federal regulations pursuant to a particular
  Federal Register notice and EPA publishes these checklists as aids to states to use for the development of
  their authorization application. See EPA's RCRA State Authorization Web Page at http://www.epa.gov/epaoswer/
  hazwaste/state/.

\2\ The legislation we are proposing to authorize contains a ``sunset provision'' by which the substantive
  requirements of the state legislation will lapse after a period of three years unless the legislature
  explicitly reauthorizes it. It is EPA's position that once program revisions are authorized, the substantive
  requirements of the legislation will remain federally enforceable and our authorization of the revised program
  will persist, until the state requests and receives authorization of superseding program revisions, despite
  any lapse in the legal effect or enforceability of statutory authority on the state level.

G. Where Are the Revised State Rules Different From the Federal Rules?

    There are no state requirements in this program revision considered
to be more stringent or broader in scope than the analogous federal
requirements.

H. Who Handles Permits After the Authorization Takes Effect?

    Michigan will continue to issue permits for all the provisions for
which it is authorized and will administer the permits it issues. EPA
will continue to administer any RCRA hazardous waste permits or
portions of permits which we issued prior to the effective date of this
authorization until they expire or are terminated. We will not issue
any more new permits or new portions of permits for the provisions
listed in the Tables above after the effective date of this
authorization. EPA will continue to implement and issue permits for
HSWA requirements for which Michigan is not yet authorized.

I. How Would Authorizing Michigan for These Revisions Affect Indian
Country (18 U.S.C. 1151) in Michigan?

    Michigan is not authorized to carry out its hazardous waste program
in Indian country within the state, as defined in 18 U.S.C. 1151. This
includes:
    1. All lands within the exterior boundaries of Indian reservations
within the State of Michigan;
    2. Any land held in trust by the U.S. for an Indian tribe; and
    3. Any other land, whether on or off an Indian reservation that
qualifies as Indian country.
    Therefore, authorizing Michigan for these revisions would not
affect Indian County in Michigan. EPA would continue to implement and
administer the RCRA program in Indian country. It is EPA's long-
standing position that the term ``Indian lands'' used in past Michigan
hazardous waste approvals is synonymous with the term ``Indian
country.'' Washington Dep't of Ecology v. U.S. EPA, 752 F.2d 1465,
1467, n.1 (9th Cir. 1985). See 40 CFR 144.3 and 258.2.

J. What Is Codification and Is EPA Codifying Michigan's Hazardous Waste
Program as Authorized in This Rule?

    Codification is the process of placing the state's statutes and
regulations that comprise the state's authorized hazardous waste
program into the Code of Federal Regulations. We do this by referencing
the authorized state rules in 40 CFR part 272. Michigan's rules, up to
and including those revised October 19, 1991, have previously been
codified through incorporation-by-reference effective April 24, 1989
(54 FR 7421, February 21, 1989); as amended effective March 31, 1992
(57 FR 3724, January 31, 1992). We reserve the amendment of 40 CFR part
272, subpart X, for the codification of Michigan's program changes
until a later date.

K. Statutory and Executive Order Reviews

    This proposed rule only authorizes hazardous waste requirements
pursuant to RCRA 3006 and imposes no requirements other than those
imposed by State law (see Supplementary Information, Section A. Why are
Revisions to State Programs Necessary?). Therefore this rule complies
with applicable executive orders and statutory provisions as follows:

1. Executive Order 18266: Regulatory Planning Review

    The Office of Management and Budget has exempted this rule from its
review

under Executive Order 12866 (58 FR 51735, October 4, 1993).

2. Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

3. Regulatory Flexibility Act

    After considering the economic impacts of today's rule on small
entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), I
certify that this rule will not have a significant economic impact on a
substantial number of small entities.

4. Unfunded Mandates Reform Act

    Because this rule approves pre-existing requirements under state
law and does not impose any additional enforceable duty beyond that
required by state law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

5. Executive Order 13132: Federalism

    Executive Order 13132 (64 FR 43255, August 10, 1999) does not apply
to this rule because it will not have federalism implications (i.e.,
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).

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

    Executive Order 13175 (65 FR 67249, November 9, 2000) does not
apply to this rule because it will not have tribal implications (i.e.,
substantial direct effects on one or more Indian tribes, 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.)

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

    This rule is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it is not economically significant as defined
in Executive Order 12866 and because the EPA does not have reason to
believe the environmental health or safety risks addressed by this
action present a disproportionate risk to children.

8. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211 (66 FR 28355, May
22, 2001), because it is not a significant regulatory action as defined
in Executive Order 12866.

9. National Technology Transfer Advancement Act

    EPA approves State programs as long as they meet criteria required
by RCRA, so it would be inconsistent with applicable law for EPA, in
its review of a State program, to require the use of any particular
voluntary consensus standard in place of another standard that meets
requirements of RCRA. Thus, the requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) do not apply to this rule.

10. Executive Order 12988

    As required by section 3 of Executive Order 12988 (61 FR 4729,
February 7, 1996), in issuing this rule, EPA has taken the necessary
steps to eliminate drafting errors and ambiguity, minimize potential
litigation, and provide a clear legal standard for affected conduct.

11. Executive Order 12630: Evaluation of Risk and Avoidance of
Unanticipated Takings

    EPA has complied with Executive Order 12630 (53 FR 8859, March 18,
1988) by examining the takings implications of the rule in accordance
with the Attorney General's Supplemental Guidelines for the Evaluation
of Risk and Avoidance of Unanticipated Takings issued under the
executive order.

12. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low Income Populations

    Because this rule proposes authorization of pre-existing state
rules and imposes no additional requirements beyond those imposed by
state law and there are no anticipated significant adverse human health
or environmental effects, the rule is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous materials transportation,
Hazardous waste, Indian-lands, Intergovernmental relations, Penalties,
Reporting and recordkeeping requirements.

    Authority: This action is issued under the authority of sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act as
amended, 42 U.S.C. 6912(a), 6926, 6974(b).

    Dated: September 26, 2007.
Bharat Mathur,
Acting Regional Administrator, Region 5.
[FR Doc. E7-19634 Filed 10-5-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 13 (Thursday, January 20, 2022)]
[Notices]
[Pages 3100-3101]
[FR Doc No: 2022-01031]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP22-482-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: TPC 2022-01-12 Negotiated Rate
Agreement to be effective 1/13/2022.
    Filed Date: 1/12/22.
    Accession Number: 20220112-5129.
    Comment Date: 5 p.m. ET 1/24/22.

    Docket Numbers: RP22-483-000.
    Applicants: Northern Border Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreements--
Housekeeping to be effective 2/12/2022.
    Filed Date: 1/12/22.
    Accession Number: 20220112-5134.
    Comment Date: 5 p.m. ET 1/24/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 13, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-01031 Filed 1-19-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Notices]
[Pages 9387-9389]
[FR Doc No: 2022-03536]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0043]

TUV SUD America, Inc.: Application for Expansion of Recognition
and Proposed Modification to the NRTL Program's List of Appropriate
Test Standards

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces the application of TUV SUD
America, Inc. (TUVAM) for expansion of recognition as a Nationally
Recognized Testing Laboratory (NRTL) and presents the agency's
preliminary finding to grant the application.

Additionally, OSHA proposes to add two test standards to the NRTL
Program's List of Appropriate Test Standards.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before March 7, 2022.

ADDRESSES: Submit comments by any of the following methods:
    Electronically: You may submit comments and attachments
electronically at: https://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Docket: To read or download comments or other material in the
docket, go to https://www.regulations.gov. Documents in the docket are
listed in the https://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through the website. All submissions, including
copyrighted material, are available for inspection through the OSHA
Docket Office. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY
(877) 889-5627) for assistance in locating docket submissions. Please
note: While OSHA's docket office is continuing to accept and process
submissions by regular mail, due to the COVID-19 pandemic, the Docket
Office is closed to the public and not able to receive submissions to
the rulemaking record by express delivery, hand delivery, and messenger
service.
    Instructions: All submissions must include the agency name and OSHA
docket number for this Federal Register notice (OSHA-2007-0043). OSHA
places comments and other materials, including any personal
information, in the public docket without revision, and these materials
will be available online at https://www.regulations.gov. Therefore, the
agency cautions commenters about submitting statements they do not want
made available to the public, or submitting comments that contain
personal information (either about themselves or others) such as Social
Security numbers, birth dates and medical data.
    Extension of comment period: Submit requests for an extension of
the comment period on or before March 7, 2022 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW, Room N-3655, Washington, DC 20210, or by fax to (202) 693-
1644.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor by phone<PHONE_NUMBER> or
email [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor by phone
(202) 693-2110 or email [email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    OSHA is providing notice that TUV SUD America, Inc. (TUVAM) is
applying for expansion of the current recognition as a NRTL. TUVAM
requests the addition of eight test standards to their NRTL scope of
recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by its
applicable test standard; and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes an application by a NRTL for initial
recognition and for an expansion or renewal of this recognition,
following requirements in Appendix A, 29 CFR 1910.7. This appendix
requires that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including TUVAM, which details the NRTL's scope of recognition. These
pages are available from the OSHA website at: https://www.osha.gov/dts/otpca/nrtl/index.html.
    TUVAM currently has seven facilities (sites) recognized by OSHA for
product testing and certification, with its headquarters located at:
TUV SUD America, Inc., 401 Edgewater Place, Suite 500, Wakefield, MA
01880. A complete list of TUVAM's scope of recognition (including
sites) recognized by OSHA is available at: https://www.osha.gov/dts/otpca/nrtl/tuvam.html.

II. General Background on the Application

    TUVAM submitted an application, dated May 26, 2021 (OSHA-2007-0043-
0038), to expand their recognition to include eight additional test
standards. OSHA staff performed detailed analysis of the application
packet and reviewed other pertinent information. OSHA did not perform
any on-site reviews in relation to this application.
    Table 1 below lists the appropriate test standards found in TUVAM's
application for expansion for testing and certification of products
under the NRTL Program.

  Table 1--Proposed List of Appropriate Test Standards for Inclusion in
                    TUVAM's NRTL Scope of Recognition
------------------------------------------------------------------------
        Test standard                     Test standard title
------------------------------------------------------------------------
UL 698A......................  Industrial Control Panels Related to
                                Hazardous (Classified) Locations.
UL 1004-9....................  Standard for Form Wound and Medium
                                Voltage Rotating Electrical Machines.
UL 60947-1...................  Low-voltage Switchgear and Controlgear--
                                Part 1: General Rules.
UL 60947-4-1.................  Standard for Low-voltage Switchgear and
                                Controlgear--Part 4-1: Contactors and
                                Motor-Starters--Electromechanical
                                Contactors and Motor-Starters.

* UL 60947-4-2...............  Low-voltage Switchgear and Controlgear--
                                Part 4-2: Contactors and Motor-Starters--
                                Electromechanical Contactors and Motor-
                                Starters.
UL 60947-5-1.................  Low-voltage Switchgear and Controlgear--
                                Part 5-1: Control Circuit Devices and
                                Switching Elements--Electromechanical
                                Control Circuit Devices.
UL 60947-5-2.................  Low-voltage Switchgear and Control Gear--
                                Part 5-2: Control Circuit Devices and
                                Switching Elements--Proximity Switches.
* UL 60947-5-5...............  Standard for Low-voltage Switchgear and
                                Controlgear--Part 5-5: Control Circuit
                                Switches and Switching Elements--
                                Electrical Emergency Stop Device with
                                Mechanical Latching Function.
------------------------------------------------------------------------
* In this notice, OSHA also proposes to add this test standard to the
  NRTL Program's List of Appropriate Test Standards.

III. Proposal To Add New Test Standards to the NRTL Program's List of
Appropriate Test Standards

    Periodically, OSHA will propose to add new test standards to the
NRTL list of appropriate test standards following an evaluation of the
test standard document. To qualify as an appropriate test standard, the
agency evaluates the document to: (1) Verify it represents a product
category for which OSHA requires certification by a NRTL; (2) verify
the document represents a product and not a component; and (3) verify
the document defines safety test specifications (not installation or
operational performance specifications). OSHA becomes aware of new test
standards through various avenues. For example, OSHA may become aware
of new test standards by: (1) Monitoring notifications issued by
certain Standards Development Organizations; (2) reviewing applications
by NRTLs or applicants seeking recognition to include new test
standards in their scopes of recognition; and (3) obtaining
notification from manufacturers, manufacturing organizations,
government agencies, or other parties. OSHA may determine to include a
new test standard in the list, for example, if the test standard is for
a particular type of product that another test standard also covers or
it covers a type of product that no standard previously covered.
    In this notice, OSHA proposes to add two new test standards to the
NRTL Program's list of appropriate test standards. Table 2, below,
lists the test standards that are new to the NRTL Program. OSHA
preliminarily determined that these test standards are appropriate test
standards. OSHA seeks public comment on this preliminary determination.

 Table 2--Standards OSHA Is Proposing To Add to the NRTL Program's List
                      of Appropriate Test Standards
------------------------------------------------------------------------
        Test standard                     Test standard title
------------------------------------------------------------------------
UL 60947-4-2.................  Low-voltage Switchgear and Control Gear--
                                Part 4-2: Contactors and Motor-Starters--
                                Electromechanical Contactors and Motor-
                                Starters.
UL 60947-5-5.................  Standard for Low-voltage Switchgear and
                                Controlgear--Part 5-5: Control Circuit
                                Switches and Switching Elements--
                                Electrical Emergency Stop Device with
                                Mechanical Latching Function.
------------------------------------------------------------------------

IV. Preliminary Findings on the Application

    TUVAM submitted an acceptable application for expansion of the NRTL
scope of recognition. OSHA's review of the application file, and
pertinent documentation, indicate that TUVAM can meet the requirements
prescribed by 29 CFR 1910.7 for expanding their recognition to include
the addition of these eight test standards for NRTL testing and
certification listed above. This preliminary finding does not
constitute an interim or temporary approval of TUVAM's application.
    OSHA welcomes public comment as to whether TUVAM meets the
requirements of 29 CFR 1910.7 for expansion of the recognition as a
NRTL. Comments should consist of pertinent written documents and
exhibits. Commenters needing more time to comment must submit a request
in writing, stating the reasons for the request. Commenters must submit
the written request for an extension by the due date for comments. OSHA
will limit any extension to 10 days unless the requester justifies a
longer period. OSHA may deny a request for an extension if the request
is not adequately justified. To obtain or review copies of the exhibits
identified in this notice, as well as comments submitted to the docket,
contact the Docket Office, at the above address. These materials also
are available online at https://www.regulations.gov under Docket No.
OSHA-2007-0043.
    OSHA staff will review all comments to the docket submitted in a
timely manner and, after addressing the issues raised by these
comments, will make a recommendation to the Assistant Secretary for
Occupational Safety and Health as to whether to grant TUVAM's
application for expansion of the scope of recognition. The Assistant
Secretary will make the final decision on granting the application. In
making this decision, the Assistant Secretary may undertake other
proceedings prescribed in Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of its final decision in the
Federal Register.

V. Authority and Signature

    Douglas L. Parker, Assistant Secretary of Labor for Occupational
Safety and Health, 200 Constitution Avenue NW, Washington, DC 20210,
authorized the preparation of this notice. Accordingly, the agency is
issuing this notice pursuant to Section 29 U.S.C. 657(g)(2), Secretary
of Labor's Order No. 8-2020 (85 FR 58393; Sept. 18, 2020), and 29 CFR
1910.7.

    Signed at Washington, DC.
Douglas L. Parker,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2022-03536 Filed 2-17-22; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45296-45298]
[FR Doc No: 2017-20799]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]

Fee for Using a Tropical Disease Priority Review Voucher in
Fiscal Year 2018

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rates for using a tropical disease priority review
voucher for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the Food and Drug Administration
Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect
priority review user fees for certain applications for approval of drug
or biological products when those applications use a tropical disease
priority review voucher awarded by the Secretary of Health and Human
Services. These vouchers are awarded to the sponsors of certain
tropical disease product applications, submitted after September 27,
2007, upon FDA approval of such applications. The amount of the fee
submitted to FDA with applications using a tropical disease priority
review voucher is determined each fiscal year based on the difference
between the average cost incurred by FDA in the review of a human drug
application subject to priority review in the previous fiscal year, and
the average cost incurred in the review of an application that is not
subject to priority review in the previous fiscal year. This notice
establishes the tropical disease priority review fee rate for FY 2018.

FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug Administration, 8455 Colesville
Rd., COLE-14202F, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1102 of FDAAA (Pub. L. 110-85) added section 524 to the
FD&C Act (21 U.S.C. 360n). In section 524, Congress encouraged
development of new drug and biological products for prevention and
treatment of certain tropical diseases by offering additional
incentives for obtaining FDA approval of such products. Under section
524, the sponsor of an eligible human drug application submitted after
September 27, 2007, for a tropical disease (as defined in section
524(a)(3) of the FD&C Act), shall receive a priority review voucher
upon approval of the tropical disease product application. The
recipient of a tropical disease priority review voucher may either use
the voucher with a future submission to FDA under section 505(b)(1) of
the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 of the Public Health
Service Act (42 U.S.C. 262), or transfer (including by sale) the
voucher to another party. The voucher may be transferred (including by
sale) repeatedly until it ultimately is used for a human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act or
section 351(a) of the Public Health Service Act. A priority review is a
review conducted with a Prescription Drug User Fee Act (PDUFA) goal
date of 6 months after the receipt or filing date, depending upon the
type of application. Information regarding the PDUFA goals is available
at: http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The applicant that uses a priority review voucher is entitled to a
priority review but must pay FDA a priority review user fee in addition
to any other fee required by PDUFA. FDA published guidance on its Web
site about how this tropical disease priority review voucher program
operates (available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080599.pdf).
    This notice establishes the tropical disease priority review fee
rate for FY 2018 as $2,830,579 and outlines FDA's process for
implementing the collection of the priority review user fees. This rate
is effective on October 1, 2017, and will remain in effect through
September 30, 2018, for applications submitted with a tropical disease
priority review voucher. The payment of this priority review user fee
is required in addition to the payment of any other fee that would
normally apply to such an application under PDUFA before FDA will
consider the application complete and acceptable for filing.

II. Tropical Disease Priority Review User Fee for FY 2018

    FDA interprets section 524(c)(2) of the FD&C Act as requiring that
FDA determine the amount of the tropical disease priority review user
fee each fiscal year based on the difference between the average cost
incurred by FDA in the review of a human drug application subject to
priority review in the previous fiscal year, and the average cost
incurred by FDA in the review of a human drug application that is not
subject to priority review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6
months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted priority
review status within this expedited timeframe. Normally, an application
for a human drug or biological product will qualify for priority review
if the product is intended to treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation will receive a standard review. Under the PDUFA goals
letter, FDA committed to reviewing and acting on 90 percent of standard
applications within 10 months of the receipt or filing date, depending
on the type of application. A priority review involves a more intensive
level of effort and a higher level of resources than a standard review.
    FDA is setting fees for FY 2018, and the previous fiscal year is FY
2017. However, the FY 2017 submission cohort has not been closed out
yet, and the cost data for FY 2017 are not complete. The latest year
for which FDA has complete cost data is FY 2016. Furthermore, because
FDA has never tracked the cost of reviewing applications that get
priority review as a separate cost subset, FDA estimated this cost
based on other data that the Agency has tracked. FDA uses data that the
Agency estimates and publishes on its Web site each year--standard
costs for review. FDA does not publish a standard cost for ``the review
of a human drug application subject to priority review in the previous
fiscal year.'' However, we expect all such applications would contain
clinical data. The standard cost application categories with clinical
data that FDA does publish each year are: (1) New drug applications
(NDAs) for a new molecular entity (NME) with clinical data and (2)
biologics license applications (BLAs).
    The worksheets for standard costs for FY 2016, show a standard cost
(rounded to the nearest hundred dollars) of $5,929,100 for a NME NDA
and $4,887,100 for a BLA. Based on these standard costs, the total cost
to review the 49 applications in these two categories in FY 2016 (27
NME NDAs with clinical data and 22 BLAs) was $267,601,900. (Note: These
numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no

investigational new drug review costs are included in this amount.)
Twenty-three of these applications (14 NDAs and 9 BLAs) received
priority review, which would mean that the remaining 26 received
standard reviews. Because a priority review compresses a review that
ordinarily takes 10 months into 6 months, FDA estimates that a
multiplier of 1.67 (10 months divided by 6 months) should be applied to
non-priority review costs in estimating the effort and cost of a
priority review as compared to a standard review. This multiplier is
consistent with published research on this subject which supports a
priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using
FY 2016 figures, the costs of a priority and standard review are
estimated using the following formula:

(23 [alpha] x 1.67) + (26 [alpha]) = $267,601,900
where ``[alpha]'' is the cost of a standard review and ``[alpha] times
1.67'' is the cost of a priority review. Using this formula, the cost
of a standard review for NME NDAs and BLAs is calculated to be
$4,154,664 (rounded to the nearest dollar) and the cost of a priority
review for NME NDAs and BLAs is 1.67 times that amount, or $6,938,289
(rounded to the nearest dollar). The difference between these two cost
estimates, or $2,783,625, represents the incremental cost of conducting
a priority review rather than a standard review.
    For the FY 2018 fee, FDA will need to adjust the FY 2016
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2017, to adjust the FY 2016 amount
for cost increases in FY 2017. That adjustment, published in the
Federal Register on July 28, 2016 (see 81 FR 49674 at 49676), setting
FY 2018 PDUFA fees, is 1.6868 percent for the most recent year, not
compounded. Increasing the FY 2016 incremental priority review cost of
$2,783,625 by 1.6868 percent (or 0.016868) results in an estimated cost
of $2,830,579 (rounded to the nearest dollar). This is the tropical
disease priority review user fee amount for FY 2018 that must be
submitted with a priority review voucher for a human drug application
in FY 2018, in addition to any PDUFA fee that is required for such an
application.

III. Fee Schedule for FY 2018

    The fee rate for FY 2018 is set out in table 1:

     Table 1--Tropical Disease Priority Review Schedule for FY 2018
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2018
------------------------------------------------------------------------
Application submitted with a tropical disease priority       $2,830,579
 review voucher in addition to the normal PDUFA fee....
------------------------------------------------------------------------

IV. Implementation of Tropical Disease Priority Review User Fee

    Under section 524(c)(4)(A) of the FD&C Act, the priority review
user fee is due upon submission of a human drug application for which
the priority review voucher is used. Section 524(c)(4)(B) of the FD&C
Act specifies that the application will be considered incomplete if the
priority review user fee and all other applicable user fees are not
paid in accordance with FDA payment procedures. In addition, FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under section 524 of the FD&C Act (see section 524(c)(4)(C))
and FDA may not collect priority review voucher fees ``except to the
extent provided in advance in appropriation Acts.'' (Section
524(c)(5)(B) of the FD&C Act.) Beginning with FDA's appropriation for
FY 2009, the annual appropriation language states specifically that
``priority review user fees authorized by 21 U.S.C. 360n [i.e., section
524 of the FD&C Act] may be credited to this account, to remain
available until expended.'' (Pub. L. 111-8, Section 5, Division A,
Title VI).
    The tropical disease priority review fee established in the new fee
schedule must be paid for any application that is received on or after
October 1, 2017, and submitted with a priority review voucher. This fee
must be paid in addition to any other fee due under PDUFA. Payment
should be made in U.S. currency by electronic check, check, bank draft,
wire transfer, credit card, or U.S. postal money order payable to the
order of the Food and Drug Administration. The preferred payment method
is online using electronic check (Automated Clearing House (ACH) also
known as eCheck). Secure electronic payments can be submitted using the
User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: Only
full payments are accepted. No partial payments can be made online).
Once you search for your invoice, select ``Pay Now'' to be redirected
to Pay.gov. Note that electronic payment options are based on the
balance due. Payment by credit card is available for balances that are
less than $25,000. If the balance exceeds this amount, only the ACH
option is available. Payments should be made using U.S bank accounts as
well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
    If paying with a paper check the user fee identification (ID)
number should be included on the check, followed by the words
``Tropical Disease Priority Review.'' All paper checks should be in
U.S. currency from a U.S. bank made payable and mailed to: Food and
Drug Administration, P.O. Box 979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only.) If you have any
questions concerning courier delivery, contact the U.S. Bank at 314-
418-4013. (This telephone number is only for questions about courier
delivery). The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full. The
account information is as follows: U.S. Dept. of Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045, Account Number: 75060099, Routing
Number: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville
Rd., 14th Floor, Silver Spring, MD 20993-0002.

V. Reference

    The following reference is on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration,

5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006.

    Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20799 Filed 9-27-17; 8:45 am]
 BILLING CODE 4164-01-P