136 
include a copy of the written request made under 
subsection (b) or (c). 
‘‘(2) IDENTIFICATION
OF
CERTAIN
DRUGS.— 
The Secretary shall publish a notice identifying any 
drug for which, on or after the date of the enact-
ment of the Best Pharmaceuticals for Children Act 
of 2007, a pediatric formulation was developed, 
studied, and found to be safe and effective in the pe-
diatric population (or specified subpopulation) if the 
pediatric formulation for such drug is not introduced 
onto the market within one year after the date that 
the Secretary publishes the notice described in para-
graph (1). Such notice identifying such drug shall be 
published not later than 30 days after the date of 
the expiration of such one year period. 
‘‘(f) INTERNAL REVIEW
OF WRITTEN REQUESTS 
AND PEDIATRIC STUDIES.— 
‘‘(1) INTERNAL REVIEW.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish an internal review committee to review 
all written requests issued on or after the date 
of the enactment of the Best Pharmaceuticals 
for Children Act of 2007, in accordance with 
paragraph (2). 
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137 
‘‘(B) MEMBERS.—The committee estab-
lished under subparagraph (A) shall include in-
dividuals with expertise in pediatrics, biophar-
macology, statistics, drugs and drug formula-
tions, legal issues, pediatric ethics, the appro-
priate expertise, such as expertise in child and 
adolescent psychiatry, pertaining to the pedi-
atric product under review, one or more experts 
from the Office of Pediatric Therapeutics, and 
other individuals designated by the Secretary. 
‘‘(2) REVIEW
OF
WRITTEN
REQUESTS.—The 
committee established under paragraph (1) shall re-
view all written requests issued pursuant to this sec-
tion prior to being issued. 
‘‘(3) TRACKING PEDIATRIC STUDIES AND LA-
BELING CHANGES.—The Secretary shall track and 
make available to the public, in an easily accessible 
manner, including through posting on the website of 
the Food and Drug Administration— 
‘‘(A) the number of studies conducted 
under this section and under section 409I of 
the Public Health Service Act; 
‘‘(B) the specific drugs and biological prod-
ucts and their uses, including labeled and off- 
labeled indications, studied under such sections; 
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138 
‘‘(C) the types of studies conducted under 
such sections, including trial design, the num-
ber of pediatric patients studied, and the num-
ber of centers and countries involved; 
‘‘(D) the number of pediatric formulations 
developed and the number of pediatric formula-
tions not developed and the reasons such for-
mulations were not developed; 
‘‘(E) the labeling changes made as a result 
of studies conducted under such sections; 
‘‘(F) an annual summary of labeling 
changes made as a result of studies conducted 
under such sections for distribution pursuant to 
subsection (k)(2); and 
‘‘(G) information regarding reports sub-
mitted on or after the date of the enactment of 
the Best Pharmaceuticals for Children Act of 
2007. 
‘‘(4) COMMITTEE.—The committee established 
under paragraph (1) shall be the committee utilized 
under section 505B(f)(1). 
‘‘(g) 
LIMITATIONS.—Notwithstanding 
subsection 
(c)(2), a drug to which the six-month period under sub-
section (b) or (c) has already been applied— 
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‘‘(1) may receive an additional six-month period 
under subsection (c)(1)(A)(i)(II) for a supplemental 
application if all other requirements under this sec-
tion are satisfied; and 
‘‘(2) may not receive any additional such period 
under subsection (c)(1)(A)(ii). 
‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE-
QUIREMENTS.—Notwithstanding any other provision of 
law, if any pediatric study is required by a provision of 
law (including a regulation) other than this section and 
such study meets the completeness, timeliness, and other 
requirements of this section, such study shall be deemed 
to satisfy the requirement for market exclusivity pursuant 
to this section. 
‘‘(i) LABELING CHANGES.— 
‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLI-
CATIONS
AND
SUPPLEMENTS.—Any application or 
supplement to an application under section 505 pro-
posing a labeling change as a result of any pediatric 
study conducted pursuant to this section— 
‘‘(A) shall be considered to be a priority 
application or supplement; and 
‘‘(B) shall be subject to the performance 
goals established by the Commissioner for pri-
ority drugs. 
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140 
‘‘(2) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST
FOR
LABELING
CHANGE 
AND FAILURE TO AGREE.—If, on or after the 
date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007, the Commis-
sioner determines that the sponsor and the 
Commissioner have been unable to reach agree-
ment on appropriate changes to the labeling for 
the drug that is the subject of the application, 
not later than 180 days after the date of sub-
mission of the application— 
‘‘(i) the Commissioner shall request 
that the sponsor of the application make 
any labeling change that the Commissioner 
determines to be appropriate; and 
‘‘(ii) if the sponsor of the application 
does not agree within 30 days after the 
Commissioner’s request to make a labeling 
change requested by the Commissioner, the 
Commissioner shall refer the matter to the 
Pediatric Advisory Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY 
COMMITTEE.—Not later than 90 days after re-
ceiving a referral under subparagraph (A)(ii), 
the Pediatric Advisory Committee shall— 
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141 
‘‘(i) review the pediatric study reports; 
and 
‘‘(ii) make a recommendation to the 
Commissioner concerning appropriate la-
beling changes, if any. 
‘‘(C) CONSIDERATION
OF
RECOMMENDA-
TIONS.—The Commissioner shall consider the 
recommendations of the Pediatric Advisory 
Committee and, if appropriate, not later than 
30 days after receiving the recommendation, 
make a request to the sponsor of the applica-
tion to make any labeling change that the Com-
missioner determines to be appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the 
application, within 30 days after receiving a re-
quest under subparagraph (C), does not agree 
to make a labeling change requested by the 
Commissioner, the Commissioner may deem the 
drug that is the subject of the application to be 
misbranded. 
‘‘(E) NO EFFECT ON AUTHORITY.—Noth-
ing in this subsection limits the authority of the 
United States to bring an enforcement action 
under this Act when a drug lacks appropriate 
pediatric labeling. Neither course of action (the 
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142 
Pediatric Advisory Committee process or an en-
forcement action referred to in the preceding 
sentence) shall preclude, delay, or serve as the 
basis to stay the other course of action. 
‘‘(j) OTHER LABELING CHANGES.—If, on or after the 
date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007, the Secretary determines that a pe-
diatric study conducted under this section does or does 
not demonstrate that the drug that is the subject of the 
study is safe and effective in pediatric populations or sub-
populations, including whether such study results are in-
conclusive, the Secretary shall order the labeling of such 
product to include information about the results of the 
study and a statement of the Secretary’s determination. 
‘‘(k) DISSEMINATION
OF
PEDIATRIC
INFORMA-
TION.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the date of submission of a report on a pedi-
atric study under this section, the Secretary shall 
make available to the public the medical, statistical, 
and clinical pharmacology reviews of pediatric stud-
ies conducted under subsection (b) or (c). 
‘‘(2) DISSEMINATION
OF
INFORMATION
RE-
GARDING
LABELING
CHANGES.—Beginning on the 
date of the enactment of the Best Pharmaceuticals 
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143 
for Children Act of 2007, the Secretary shall include 
as a requirement of a written request that the spon-
sors of the studies that result in labeling changes 
that are reflected in the annual summary developed 
pursuant to subsection (f)(3)(F) distribute, at least 
annually (or more frequently if the Secretary deter-
mines that it would be beneficial to the public 
health), such information to physicians and other 
health care providers. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this 
subsection alters or amends section 301(j) of this 
Act or section 552 of title 5 or section 1905 of title 
18, United States Code. 
‘‘(l) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING IN YEAR ONE.—Beginning on 
the date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007, during the one- 
year period beginning on the date a labeling change 
is approved pursuant to subsection (i), the Secretary 
shall ensure that all adverse event reports that have 
been received for such drug (regardless of when such 
report was received) are referred to the Office of Pe-
diatric Therapeutics established under section 6 of 
the Best Pharmaceuticals for Children Act (Public 
Law 107–109). In considering the reports, the Di-
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144 
rector of such Office shall provide for the review of 
the reports by the Pediatric Advisory Committee, in-
cluding obtaining any recommendations of such 
Committee regarding whether the Secretary should 
take action under this Act in response to such re-
ports. 
‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Fol-
lowing the one-year period described in paragraph 
(1), the Secretary shall, as appropriate, refer to the 
Office of Pediatric Therapeutics all pediatric adverse 
event reports for a drug for which a pediatric study 
was conducted under this section. In considering 
such reports, the Director of such Office may pro-
vide for the review of such reports by the Pediatric 
Advisory Committee, including obtaining any rec-
ommendation of such Committee regarding whether 
the Secretary should take action in response to such 
reports. 
‘‘(3) EFFECT.—The requirements of this sub-
section shall supplement, not supplant, other review 
of such adverse event reports by the Secretary. 
‘‘(m) CLARIFICATION OF INTERACTION OF MARKET 
EXCLUSIVITY UNDER THIS SECTION AND MARKET EX-
CLUSIVITY AWARDED TO AN APPLICANT FOR APPROVAL 
OF A DRUG UNDER SECTION 505(j).—If a 180-day period 
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under section 505(j)(5)(B)(iv) overlaps with a 6-month ex-
clusivity period under this section, so that the applicant 
for approval of a drug under section 505(j) entitled to the 
180-day period under that section loses a portion of the 
180-day period to which the applicant is entitled for the 
drug, the 180-day period shall be extended from— 
‘‘(1) the date on which the 180-day period 
would have expired by the number of days of the 
overlap, if the 180-day period would, but for the ap-
plication of this subsection, expire after the 6-month 
exclusivity period; or 
‘‘(2) the date on which the 6-month exclusivity 
period expires, by the number of days of the overlap 
if the 180-day period would, but for the application 
of this subsection, expire during the six-month exclu-
sivity period. 
‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COM-
PLETED.— 
‘‘(1) IN GENERAL.—Beginning on the date of 
the enactment of the Best Pharmaceuticals for Chil-
dren Act of 2007, if pediatric studies have not been 
completed under subsection (d) and if the Secretary, 
through the committee established under subsection 
(f), determines that there is a continuing need for 
information relating to the use of the drug in the pe-
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146 
diatric population (including neonates, as appro-
priate), the Secretary shall— 
‘‘(A) for a drug for which listed patents 
have not expired, make a determination regard-
ing whether an assessment shall be required to 
be submitted under section 505B; or 
‘‘(B) for a drug that has no listed patents 
or has 1 or more listed patents that have ex-
pired, determine whether there are funds avail-
able under section 736 to award a grant to con-
duct the requested studies pursuant to para-
graph (2). 
‘‘(2) FUNDING OF STUDIES.—If, pursuant to 
paragraph (1), the Secretary determines that there 
are funds available under section 736 to award a 
grant to conduct the requested pediatric studies, 
then the Secretary shall issue a proposal to award 
a grant to conduct the requested studies. If the Sec-
retary determines that funds are not available under 
section 736, the Secretary shall refer the drug for 
inclusion on the list established under section 409I 
of the Public Health Service Act or the conduct of 
studies. 
‘‘(3) PUBLIC NOTICE.—The Secretary shall give 
the public notice of— 
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147 
‘‘(A) a decision under paragraph (1)(A) 
not to require an assessment under section 
505B and the basis for such decision; 
‘‘(B) the name of any drug, its manufac-
turer, and the indications to be studied pursu-
ant to a grant made under paragraph (2); and 
‘‘(C) any decision under paragraph (2) to 
include a drug on the list established under sec-
tion 409I of the Public Health Service Act. 
‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 
subsection alters or amends section 301(j) of this 
Act or section 552 of title 5 or section 1905 of title 
18, United States Code. 
‘‘(o) PROMPT APPROVAL OF DRUGS UNDER SECTION 
505(j) WHEN PEDIATRIC INFORMATION IS ADDED TO LA-
BELING.— 
‘‘(1) GENERAL RULE.—A drug for which an ap-
plication has been submitted or approved under sec-
tion 505(j) shall not be considered ineligible for ap-
proval under that section or misbranded under sec-
tion 502 on the basis that the labeling of the drug 
omits a pediatric indication or any other aspect of 
labeling pertaining to pediatric use when the omitted 
indication or other aspect is protected by patent or 
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148 
by exclusivity under clause (iii) or (iv) of section 
505(j)(5)(F). 
‘‘(2) LABELING.—Notwithstanding clauses (iii) 
and (iv) of section 505(j)(5)(F), the Secretary may 
require that the labeling of a drug approved under 
section 505(j) that omits a pediatric indication or 
other aspect of labeling as described in paragraph 
(1) include— 
‘‘(A) a statement that, because of mar-
keting exclusivity for a manufacturer— 
‘‘(i) the drug is not labeled for pedi-
atric use; or 
‘‘(ii) in the case of a drug for which 
there is an additional pediatric use not re-
ferred to in paragraph (1), the drug is not 
labeled for the pediatric use under para-
graph (1); and 
‘‘(B) a statement of any appropriate pedi-
atric 
contraindications, 
warnings, 
or 
pre-
cautions that the Secretary considers necessary. 
‘‘(3) PRESERVATION
OF
PEDIATRIC
EXCLU-
SIVITY
AND
OTHER
PROVISIONS.—This subsection 
does not affect— 
‘‘(A) the availability or scope of exclusivity 
under this section; 
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149 
‘‘(B) the availability or scope of exclusivity 
under section 505 for pediatric formulations; 
‘‘(C) the question of the eligibility for ap-
proval of any application under section 505(j) 
that omits any other conditions of approval en-
titled to exclusivity under clause (iii) or (iv) of 
section 505(j)(5)(F); or 
‘‘(D) except as expressly provided in para-
graphs (1) and (2), the operation of section 
505. 
‘‘(p) INSTITUTE OF MEDICINE STUDY.—Not later 
than 3 years after the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007, the Secretary 
shall enter into a contract with the Institute of Medicine 
to conduct a study and report to Congress regarding the 
written requests made and the studies conducted pursuant 
to this section. The Institute of Medicine may devise an 
appropriate mechanism to review a representative sample 
of requests made and studies conducted pursuant to this 
section in order to conduct such study. Such study shall— 
‘‘(1) review such representative written requests 
issued by the Secretary since 1997 under sub-
sections (b) and (c); 
‘‘(2) review and assess such representative pedi-
atric studies conducted under subsections (b) and (c) 
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150 
since 1997 and labeling changes made as a result of 
such studies; 
‘‘(3) review the use of extrapolation for pedi-
atric subpopulations, the use of alternative endpoints 
for pediatric populations, neonatal assessment tools, 
and ethical issues in pediatric clinical trials; and 
‘‘(4) make recommendations regarding appro-
priate incentives for encouraging pediatric studies of 
biologics. 
‘‘(q) SUNSET.—A drug may not receive any 6-month 
period under subsection (b) or (c) unless— 
‘‘(1) on or before October 1, 2012, the Sec-
retary makes a written request for pediatric studies 
of the drug; 
‘‘(2) on or before October 1, 2012, an applica-
tion for the drug is accepted for filing under section 
505(b); and 
‘‘(3) all requirements of this section are met.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by this subsection shall apply to written requests 
under section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) made after the date 
of the enactment of this Act. 
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151 
(b) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 
Section 409I of the Public Health Service Act (42 U.S.C. 
284m) is amended to read as follows: 
‘‘SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
‘‘(a) LIST
OF
PRIORITY
ISSUES
IN
PEDIATRIC 
THERAPEUTICS.— 
‘‘(1) IN GENERAL.—Not later than one year 
after the date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007, the Secretary, 
acting through the Director of the National Insti-
tutes of Health and in consultation with the Com-
missioner of Food and Drugs and experts in pedi-
atric research, shall develop and publish a priority 
list of needs in pediatric therapeutics, including 
drugs or indications that require study. The list 
shall be revised every three years. 
‘‘(2) CONSIDERATION OF AVAILABLE INFORMA-
TION.—In developing and prioritizing the list under 
paragraph (1), the Secretary shall consider— 
‘‘(A) therapeutic gaps in pediatrics that 
may 
include 
developmental 
pharmacology, 
pharmacogenetic determinants of drug re-
sponse, metabolism of drugs and biologics in 
children, and pediatric clinical trials; 
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152 
‘‘(B) particular pediatric diseases, dis-
orders or conditions where more complete 
knowledge and testing of therapeutics, including 
drugs and biologics, may be beneficial in pedi-
atric populations; and 
‘‘(C) the adequacy of necessary infrastruc-
ture to conduct pediatric pharmacological re-
search, including research networks and trained 
pediatric investigators. 
‘‘(b) PEDIATRIC STUDIES
AND RESEARCH.—The 
Secretary, acting through the National Institutes of 
Health, shall award funds to entities that have the exper-
tise to conduct pediatric clinical trials or other research 
(including qualified universities, hospitals, laboratories, 
contract research organizations, practice groups, federally 
funded programs such as pediatric pharmacology research 
units, other public or private institutions, or individuals) 
to enable the entities to conduct the drug studies or other 
research on the issues described in subsection (a). The 
Secretary may use contracts, grants, or other appropriate 
funding mechanisms to award funds under this subsection. 
‘‘(c) PROCESS
FOR PROPOSED PEDIATRIC STUDY 
REQUESTS AND LABELING CHANGES.— 
‘‘(1) SUBMISSION
OF
PROPOSED
PEDIATRIC 
STUDY REQUEST.—The Director of the National In-
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153 
stitutes of Health shall, as appropriate, submit pro-
posed pediatric study requests for consideration by 
the Commissioner of Food and Drugs for pediatric 
studies of a specific pediatric indication identified 
under subsection (a). Such a proposed pediatric 
study request shall be made in a manner equivalent 
to a written request made under subsection (b) or 
(c) of section 505A of the Federal Food, Drug, and 
Cosmetic Act, including with respect to the informa-
tion provided on the pediatric studies to be con-
ducted pursuant to the request. The Director of the 
National Institutes of Health may submit a pro-
posed pediatric study request for a drug for which— 
‘‘(A)(i) there is an approved application 
under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act; or 
‘‘(ii) there is a submitted application that 
could be approved under the criteria of such 
section; and 
‘‘(B) there is no patent protection or mar-
ket exclusivity protection for at least one form 
of the drug under the Federal Food, Drug, and 
Cosmetic Act; and 
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154 
‘‘(C) additional studies are needed to as-
sess the safety and effectiveness of the use of 
the drug in the pediatric population. 
‘‘(2) WRITTEN REQUEST TO HOLDERS OF AP-
PROVED APPLICATIONS FOR DRUGS LACKING EXCLU-
SIVITY.—The Commissioner of Food and Drugs, in 
consultation with the Director of the National Insti-
tutes of Health, may issue a written request based 
on the proposed pediatric study request for the indi-
cation or indications submitted pursuant to para-
graph (1) (which shall include a timeframe for nego-
tiations for an agreement) for pediatric studies con-
cerning a drug identified under subsection (a) to all 
holders of an approved application for the drug 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act. Such a written request shall be made 
in a manner equivalent to the manner in which a 
written request is made under subsection (b) or (c) 
of section 505A of such Act, including with respect 
to information provided on the pediatric studies to 
be conducted pursuant to the request and using ap-
propriate formulations for each age group for which 
the study is requested. 
‘‘(3) REQUESTS FOR PROPOSALS.—If the Com-
missioner of Food and Drugs does not receive a re-
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155 
sponse to a written request issued under paragraph 
(2) not later than 30 days after the date on which 
a request was issued, the Secretary, acting through 
the Director of the National Institutes of Health and 
in consultation with the Commissioner of Food and 
Drugs, shall publish a request for proposals to con-
duct the pediatric studies described in the written 
request in accordance with subsection (b). 
‘‘(4) DISQUALIFICATION.—A holder that re-
ceives a first right of refusal shall not be entitled to 
respond to a request for proposals under paragraph 
(3). 
‘‘(5) CONTRACTS, GRANTS, OR OTHER FUNDING 
MECHANISMS.—A contract, grant, or other funding 
may be awarded under this section only if a proposal 
is submitted to the Secretary in such form and man-
ner, and containing such agreements, assurances, 
and information as the Secretary determines to be 
necessary to carry out this section. 
‘‘(6) REPORTING OF STUDIES.— 
‘‘(A) IN
GENERAL.—On completion of a 
pediatric study in accordance with an award 
under this section, a report concerning the 
study shall be submitted to the Director of the 
National Institutes of Health and the Commis-
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156 
sioner of Food and Drugs. The report shall in-
clude all data generated in connection with the 
study, including a written request if issued. 
‘‘(B) AVAILABILITY
OF
REPORTS.—Each 
report submitted under subparagraph (A) shall 
be considered to be in the public domain (sub-
ject to section 505A(d)(4) of the Federal Food, 
Drug, and Cosmetic Act) and shall be assigned 
a docket number by the Commissioner of Food 
and Drugs. An interested person may submit 
written comments concerning such pediatric 
studies to the Commissioner of Food and 
Drugs, and the written comments shall become 
part of the docket file with respect to each of 
the drugs. 
‘‘(C) ACTION
BY
COMMISSIONER.—The 
Commissioner of Food and Drugs shall take ap-
propriate action in response to the reports sub-
mitted under subparagraph (A) in accordance 
with paragraph (7). 
‘‘(7) REQUESTS FOR LABELING CHANGE.—Dur-
ing the 180-day period after the date on which a re-
port is submitted under paragraph (6)(A), the Com-
missioner of Food and Drugs shall— 
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‘‘(A) review the report and such other data 
as are available concerning the safe and effec-
tive use in the pediatric population of the drug 
studied; 
‘‘(B) negotiate with the holders of ap-
proved applications for the drug studied for any 
labeling changes that the Commissioner of Food 
and Drugs determines to be appropriate and re-
quests the holders to make; and 
‘‘(C)(i) place in the public docket file a 
copy of the report and of any requested labeling 
changes; and 
‘‘(ii) publish in the Federal Register and 
through a posting on the website of the Food 
and Drug Administration a summary of the re-
port and a copy of any requested labeling 
changes. 
‘‘(8) DISPUTE RESOLUTION.— 
‘‘(A) REFERRAL TO PEDIATRIC ADVISORY 
COMMITTEE.—If, not later than the end of the 
180-day period specified in paragraph (7), the 
holder of an approved application for the drug 
involved does not agree to any labeling change 
requested by the Commissioner of Food and 
Drugs under that paragraph, the Commissioner 
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of Food and Drugs shall refer the request to 
the Pediatric Advisory Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY 
COMMITTEE.—Not later than 90 days after re-
ceiving a referral under subparagraph (A), the 
Pediatric Advisory Committee shall— 
‘‘(i) review the available information 
on the safe and effective use of the drug 
in the pediatric population, including study 
reports submitted under this section; and 
‘‘(ii) make a recommendation to the 
Commissioner of Food and Drugs as to ap-
propriate labeling changes, if any. 
‘‘(9) FDA DETERMINATION.—Not later than 30 
days after receiving a recommendation from the Pe-
diatric 
Advisory 
Committee 
under 
paragraph 
(8)(B)(ii) with respect to a drug, the Commissioner 
of Food and Drugs shall consider the recommenda-
tion and, if appropriate, make a request to the hold-
ers of approved applications for the drug to make 
any labeling change that the Commissioner of Food 
and Drugs determines to be appropriate. 
‘‘(10) FAILURE TO AGREE.—If a holder of an 
approved application for a drug, within 30 days 
after receiving a request to make a labeling change 
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