82_FR_29205 82 FR 29083 - Supplemental Evidence and Data Request on Drug Therapy for Early Rheumatoid Arthritis in Adults-An Update

82 FR 29083 - Supplemental Evidence and Data Request on Drug Therapy for Early Rheumatoid Arthritis in Adults-An Update

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 122 (June 27, 2017)

Page Range29083-29085
FR Document2017-13395

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Drug Therapy for Early Rheumatoid Arthritis in Adults--An Update, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

Federal Register, Volume 82 Issue 122 (Tuesday, June 27, 2017) 
[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Notices]
[Pages 29083-29085]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Drug Therapy for Early 
Rheumatoid Arthritis in Adults--An Update

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Drug Therapy for 
Early Rheumatoid Arthritis in Adults--An Update, which is currently 
being conducted by the AHRQ's Evidence-based Practice Centers (EPC) 
Program. Access to published and unpublished pertinent scientific 
information will improve the quality of this review.

DATES: Submission Deadline on or before July 27, 2017.

ADDRESSES: Email submissions: src.org">SEADS@epc-src.org.
    Print submissions:
    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator, P.O. 
Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 
71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">SEADS@epc-src.org.

SUPPLEMENTARY INFORMATION: AHRQ is conducting this systematic review 
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 
299a(a). The Agency for Healthcare Research and Quality has 
commissioned the Evidence-based Practice Centers (EPC) Program to 
complete a review of the evidence for Drug Therapy for Early Rheumatoid 
Arthritis in Adults--An Update.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Drug Therapy for Early Rheumatoid Arthritis in Adults--
An Update, including those that describe adverse events. The entire 
research protocol, including the key questions, is also available 
online at: https://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2475.
    This is to notify the public that the EPC Program would find the 
following information on Drug Therapy for Early Rheumatoid Arthritis in 
Adults--An Update helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov,

[[Page 29084]]

please provide a summary, including the following elements: Study 
number, study period, design, methodology, indication and diagnosis, 
proper use instructions, inclusion and exclusion criteria, primary and 
secondary outcomes, baseline characteristics, number of patients 
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, 
effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. 
Materials submitted must be publicly available or able to be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Key Questions

Key Question (KQ) 1

    For patients with early Rheumatoid Arthritis (RA), do drug 
therapies differ in their ability to reduce disease activity, slow or 
limit the progression of radiographic joint damage, or induce 
remission?

KQ 2

    For patients with early RA, do drug therapies differ in their 
ability to improve patient-reported symptoms, functional capacity, or 
quality of life?

KQ 3

    For patients with early RA, do drug therapies differ in harms, 
tolerability, patient adherence, or adverse effects?

KQ 4

    What are the comparative benefits and harms of drug therapies for 
early RA in subgroups of patients based on disease activity, prior 
therapy, demographics (e.g., women in their childbearing years), 
concomitant therapies, and presence of other serious conditions?

Contextual Questions (CQs)

    Contextual questions are not systematically reviewed and use a 
``best evidence'' approach. Information about the contextual questions 
may be included as part of the introduction or discussion section and 
related as appropriate to the Systematic Review.

CQ 1

    Does treatment of early RA improve disease trajectory and disease 
outcomes compared with the trajectory or outcomes of treatment of 
established RA?

CQ 2

    What barriers prevent individuals with early RA from obtaining 
access to indicated drug therapies?

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

Populations

Inclusion
I. All KQs: Adult outpatients ages 19 or older with an early RA 
diagnosis, defined as 1 year or less from disease diagnosis; we will 
include studies with mixed populations if >50% of study populations had 
an early RA diagnosis
II. KQ 4 only: Subpopulations by age, sex/gender, race/ethnicity, 
disease activity, prior therapies, concomitant therapies, and other 
serious conditions
Exclusion
    Adolescents and adult patients with disease greater than 1 year 
from diagnosis.

Intervention/Exposure

Inclusion
I. FDA approved
    A. Corticosteroids: Methylprednisolone, prednisone, prednisolone
    B. csDMARDs: Hydroxychloroquine, leflunomide, methotrexate, 
sulfasalazine
    C. TNF biologics: Adalimumab, certolizumab pegol, etanercept, 
golimumab, infliximab
    D. Non-TNF biologics: Abatacept, rituximab, tocilizumab
    E. tsDMARDs: Tofacitinib
    F. Biosimilars: Adalimumab-atto, infliximab-dyyb, infliximab-abda, 
etanercept-szzs
II. Under review by FDA
    A. Non-TNF biologics: Sarilumab, sirukumab
Exclusion
    Anakinra is excluded because, although it is approved for RA, 
clinically it is not used anymore for this population.

Comparator

Inclusion
I. For head-to-head RCTs, head-to-head nRCTs, and prospective, 
controlled cohort studies (all KQs): Any active intervention listed 
above
II. For additional observational studies of harms (i.e., overall [KQ 3] 
and among subgroups [KQ 4]: Any active intervention listed above or no 
comparator (e.g., postmarketing surveillance study of an active 
intervention with no comparison group)
III. For double-blinded, placebo-controlled trials for network meta-
analysis (all KQs): Placebo
Exclusion
    All other comparisons, including active interventions not listed 
above.

Outcomes

Inclusion
I. KQs 1, 4: Disease activity, radiographic joint damage, remission
II. KQs 2, 4: Functional capacity, quality of life, patient-reported 
symptoms
III. KQs 3, 4: Overall risk of harms, overall discontinuation, 
discontinuation because of adverse effects, risk of serious adverse 
effects, specific adverse effects, patient adherence
Exclusion
    All other outcomes not listed.

Timing

Inclusion
    All KQs: At least 3 months of treatment.
Exclusion
    <3 months treatment.

[[Page 29085]]

Settings

Inclusion
    All KQs: Outpatients.
Exclusion
    Inpatients.

Country Setting

Inclusion
    All KQs: Any geographic area.
Exclusion
    None.

Study Designs

Inclusion
I. For all KQs (i.e., benefits and harms overall [KQs 1, 2, 3] and 
among subgroups [KQ 4]), we will include head-to head RCTs and nRCTs; 
prospective, controlled cohort studies (N >= 100); double-blinded, 
placebo-controlled trials for network meta-analysis; and SRs for 
identification of additional references only.
II. For studies of harms (i.e., overall [KQ 3] and among subgroups [KQ 
4]), we will also include any other observational study (e.g., cohort, 
case-control, large case series, post marketing surveillance) (N >= 
100).
Exclusion
    All other designs not listed.

Publication Language

Inclusion
    All KQs: English.
Exclusion
    Languages other than English.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-13395 Filed 6-26-17; 8:45 am]
 BILLING CODE 4160-90-P

Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices 29083 these priority populations are matters related to AHRQ’s conduct of its AHRQ’s Evidence-based Practice encouraged. mission including providing guidance Centers (EPC) Program. Access to on (A) priorities for health care research, published and unpublished pertinent Sharon B. Arnold, (B) the field of health care research scientific information will improve the Deputy Director. including training needs and quality of this review. [FR Doc. 2017–13396 Filed 6–26–17; 8:45 am] information dissemination on health DATES: Submission Deadline on or BILLING CODE 4160–90–P care quality and (C) the role of the before July 27, 2017. Agency in light of private sector activity ADDRESSES: Email submissions: and opportunities for public private SEADS@epc-src.org. DEPARTMENT OF HEALTH AND partnerships. The Council is composed HUMAN SERVICES Print submissions: of members of the public, appointed by Mailing Address: Portland VA Agency for Healthcare Research and the Secretary, and Federal ex-officio Research Foundation, Scientific Quality members specified in the authorizing Resource Center, ATTN: Scientific legislation. Information Packet Coordinator, P.O. Meeting of the National Advisory II. Agenda Box 69539, Portland, OR 97239. Council for Healthcare Research and Shipping Address (FedEx, UPS, etc.): Quality On Wednesday, July 26, 2017, there Portland VA Research Foundation, will be a subcommittee meeting for the Scientific Resource Center, ATTN: AGENCY: Agency for Healthcare Research National Healthcare Quality and Scientific Information Packet and Quality (AHRQ), HHS. Disparities Report scheduled to begin at Coordinator, 3710 SW U.S. Veterans ACTION: Notice of public meeting. 7:30 a.m. This meeting is open to the Hospital Road, Mail Code: R&D 71, public. The Council meeting will Portland, OR 97239. SUMMARY: In accordance with the convene at 8:30 a.m., with the call to FOR FURTHER INFORMATION CONTACT: Federal Advisory Committee Act, this order by the Council Chair and approval notice announces a meeting of the Ryan McKenna, Telephone: 503–220– of previous Council summary notes. The National Advisory Council for 8262 ext. 51723 or Email: SEADS@epc- meeting is open to the public and will Healthcare Research and Quality. src.org. be available via webcast at SUPPLEMENTARY INFORMATION: AHRQ is DATES: The meeting will be held on www.webconferences.com/ahrq. The Wednesday, July 26, 2017, from 8:30 meeting will begin with an update on conducting this systematic review a.m. to 2:45 p.m. AHRQ’s current research, programs, and pursuant to Section 902(a) of the Public initiatives. The agenda will also include Health Service Act, 42 U.S.C. 299a(a). ADDRESSES: The meeting will be held at an update on AHRQ’s work in learning The Agency for Healthcare Research and AHRQ, 5600 Fishers Lane, Rockville, Quality has commissioned the Maryland, 20857. health care systems and AHRQ’s EvidenceNOW initiative, and will focus Evidence-based Practice Centers (EPC) FOR FURTHER INFORMATION CONTACT: Program to complete a review of the Jaime Zimmerman, Designated on the use of AHRQ data and analytics to answer emerging policy questions. evidence for Drug Therapy for Early Management Official, at the Agency for Rheumatoid Arthritis in Adults—An Healthcare Research and Quality, 5600 The final agenda will be available on the AHRQ Web site at www.AHRQ.gov no Update. Fishers Lane, Mail Stop 06E37A, The EPC Program is dedicated to Rockville, Maryland 20857, (301) 427– later than Wednesday, July 19, 2017. identifying as many studies as possible 1456. For press-related information, Sharon B. Arnold, that are relevant to the questions for please contact Alison Hunt at (301) 427– Deputy Director. each of its reviews. In order to do so, we 1244 or Alison.Hunt@ahrq.hhs.gov. [FR Doc. 2017–13393 Filed 6–26–17; 8:45 am] are supplementing the usual manual If sign language interpretation or other BILLING CODE 4160–90–P and electronic database searches of the reasonable accommodation for a literature by requesting information disability is needed, please contact the from the public (e.g., details of studies Food and Drug Administration (FDA) DEPARTMENT OF HEALTH AND conducted). We are looking for studies Office of Equal Employment HUMAN SERVICES that report on Drug Therapy for Early Opportunity and Diversity Management Rheumatoid Arthritis in Adults—An on (301) 827–4840, no later than Agency for Healthcare Research and Update, including those that describe Wednesday, July 19, 2017. The agenda, Quality adverse events. The entire research roster, and minutes will be available protocol, including the key questions, is from Ms. Bonnie Campbell, Committee Supplemental Evidence and Data also available online at: https://effective Management Officer, Agency for Request on Drug Therapy for Early healthcare.ahrq.gov/search-for-guides- Healthcare Research and Quality, 5600 Rheumatoid Arthritis in Adults—An reviews-and-reports/?pageaction= Fishers Lane, Rockville, Maryland Update displayproduct&productID=2475. 20857. Ms. Campbell’s phone number is AGENCY: Agency for Healthcare Research This is to notify the public that the (301) 427–1554. and Quality (AHRQ), HHS. EPC Program would find the following SUPPLEMENTARY INFORMATION: ACTION: Request for supplemental information on Drug Therapy for Early evidence and data submissions. Rheumatoid Arthritis in Adults—An I. Purpose Update helpful: The National Advisory Council for SUMMARY: The Agency for Healthcare D A list of completed studies that mstockstill on DSK30JT082PROD with NOTICES Healthcare Research and Quality is Research and Quality (AHRQ) is seeking your organization has sponsored for this authorized by Section 941 of the Public scientific information submissions from indication. In the list, please indicate Health Service Act, 42 U.S.C. 299c. In the public. Scientific information is whether results are available on accordance with its statutory mandate, being solicited to inform our review of ClinicalTrials.gov along with the the Council is to advise the Secretary of Drug Therapy for Early Rheumatoid ClinicalTrials.gov trial number. the Department of Health and Human Arthritis in Adults—An Update, which D For completed studies that do not Services and the Director of AHRQ on is currently being conducted by the have results on ClinicalTrials.gov, VerDate Sep<11>2014 18:33 Jun 26, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\27JNN1.SGM 27JNN1

29084 Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices please provide a summary, including KQ 3 C. TNF biologics: Adalimumab, the following elements: Study number, For patients with early RA, do drug certolizumab pegol, etanercept, study period, design, methodology, therapies differ in harms, tolerability, golimumab, infliximab indication and diagnosis, proper use patient adherence, or adverse effects? D. Non-TNF biologics: Abatacept, instructions, inclusion and exclusion rituximab, tocilizumab criteria, primary and secondary KQ 4 E. tsDMARDs: Tofacitinib outcomes, baseline characteristics, What are the comparative benefits and F. Biosimilars: Adalimumab-atto, number of patients screened/eligible/ harms of drug therapies for early RA in infliximab-dyyb, infliximab-abda, enrolled/lost to follow-up/withdrawn/ subgroups of patients based on disease etanercept-szzs analyzed, effectiveness/efficacy, and activity, prior therapy, demographics safety results. II. Under review by FDA (e.g., women in their childbearing D A list of ongoing studies that your A. Non-TNF biologics: Sarilumab, years), concomitant therapies, and organization has sponsored for this sirukumab presence of other serious conditions? indication. In the list, please provide the Exclusion ClinicalTrials.gov trial number or, if the Contextual Questions (CQs) trial is not registered, the protocol for Contextual questions are not Anakinra is excluded because, the study including a study number, the systematically reviewed and use a ‘‘best although it is approved for RA, study period, design, methodology, evidence’’ approach. Information about clinically it is not used anymore for this indication and diagnosis, proper use the contextual questions may be population. instructions, inclusion and exclusion included as part of the introduction or Comparator criteria, and primary and secondary discussion section and related as outcomes. Inclusion D Description of whether the above appropriate to the Systematic Review. studies constitute ALL Phase II and CQ 1 I. For head-to-head RCTs, head-to-head above clinical trials sponsored by your nRCTs, and prospective, controlled Does treatment of early RA improve cohort studies (all KQs): Any active organization for this indication and an disease trajectory and disease outcomes intervention listed above index outlining the relevant information compared with the trajectory or II. For additional observational studies in each submitted file. Your contribution will be very outcomes of treatment of established of harms (i.e., overall [KQ 3] and beneficial to the EPC Program. Materials RA? among subgroups [KQ 4]: Any submitted must be publicly available or CQ 2 active intervention listed above or able to be made public. Materials that no comparator (e.g., postmarketing What barriers prevent individuals are considered confidential; marketing surveillance study of an active with early RA from obtaining access to materials; study types not included in intervention with no comparison indicated drug therapies? the review; or information on group) indications not included in the review PICOTS (Populations, Interventions, III. For double-blinded, placebo- cannot be used by the EPC Program. Comparators, Outcomes, Timing, controlled trials for network meta- This is a voluntary request for Settings) analysis (all KQs): Placebo information, and all costs for complying with this request must be borne by the Populations Exclusion submitter. Inclusion All other comparisons, including The draft of this review will be posted active interventions not listed above. on AHRQ’s EPC Program Web site and I. All KQs: Adult outpatients ages 19 or available for public comment for a older with an early RA diagnosis, Outcomes period of 4 weeks. If you would like to defined as 1 year or less from disease diagnosis; we will include Inclusion be notified when the draft is posted, please sign up for the email list at: studies with mixed populations if I. KQs 1, 4: Disease activity, https://www.effectivehealthcare.ahrq. >50% of study populations had an radiographic joint damage, gov/index.cfm/join-the-email-list1/. early RA diagnosis remission The systematic review will answer the II. KQ 4 only: Subpopulations by age, II. KQs 2, 4: Functional capacity, quality following questions. This information is sex/gender, race/ethnicity, disease of life, patient-reported symptoms provided as background. AHRQ is not activity, prior therapies, concomitant therapies, and other III. KQs 3, 4: Overall risk of harms, requesting that the public provide overall discontinuation, answers to these questions. serious conditions discontinuation because of adverse The Key Questions Exclusion effects, risk of serious adverse Adolescents and adult patients with effects, specific adverse effects, Key Question (KQ) 1 disease greater than 1 year from patient adherence For patients with early Rheumatoid diagnosis. Arthritis (RA), do drug therapies differ Exclusion in their ability to reduce disease Intervention/Exposure All other outcomes not listed. activity, slow or limit the progression of Inclusion radiographic joint damage, or induce Timing mstockstill on DSK30JT082PROD with NOTICES remission? I. FDA approved Inclusion A. Corticosteroids: KQ 2 Methylprednisolone, prednisone, All KQs: At least 3 months of For patients with early RA, do drug prednisolone treatment. therapies differ in their ability to B. csDMARDs: Hydroxychloroquine, Exclusion improve patient-reported symptoms, leflunomide, methotrexate, functional capacity, or quality of life? sulfasalazine <3 months treatment. VerDate Sep<11>2014 18:33 Jun 26, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\27JNN1.SGM 27JNN1

Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices 29085 Settings scientific information submissions from pageaction=displayproduct& the public. Scientific information is productid=2478. Inclusion This is to notify the public that the being solicited to inform our review of All KQs: Outpatients. Psychological and Pharmacological EPC Program would find helpful the Treatments for Adults with following information on Psychological Exclusion Posttraumatic Stress Disorder (PTSD): A and Pharmacological Treatments for Inpatients. Systematic Review Update, which is Adults with Posttraumatic Stress Country Setting currently being conducted by the Disorder (PTSD): A Systematic Review AHRQ’s Evidence-based Practice Update: Inclusion Centers (EPC) Program. Access to D A list of completed studies that All KQs: Any geographic area. published and unpublished pertinent your organization has sponsored for this scientific information will improve the indication. In the list, please indicate Exclusion quality of this review. whether results are available on None. ClinicalTrials.gov along with the DATES: Submission Deadline on or ClinicalTrials.gov trial number. Study Designs before July 27, 2017. D For completed studies that do not ADDRESSES: have results on ClinicalTrials.gov, Inclusion Email submissions: SEADS@epc- please provide a summary, including I. For all KQs (i.e., benefits and harms src.org. the following elements: Study number, overall [KQs 1, 2, 3] and among Print submissions: study period, design, methodology, subgroups [KQ 4]), we will include Mailing Address: Portland VA indication and diagnosis, proper use head-to head RCTs and nRCTs; Research Foundation, Scientific instructions, inclusion and exclusion prospective, controlled cohort Resource Center, ATTN: Scientific criteria, primary and secondary studies (N ≥ 100); double-blinded, Information Packet Coordinator, P.O. outcomes, baseline characteristics, placebo-controlled trials for Box 69539, Portland, OR 97239. number of patients screened/eligible/ network meta-analysis; and SRs for Shipping Address (FedEx, UPS, etc.): enrolled/lost to follow-up/withdrawn/ identification of additional Portland VA Research Foundation, analyzed, effectiveness/efficacy, and references only. Scientific Resource Center, ATTN: safety results. II. For studies of harms (i.e., overall [KQ Scientific Information Packet D A list of ongoing studies that your 3] and among subgroups [KQ 4]), Coordinator, 3710 SW U.S. Veterans organization has sponsored for this we will also include any other Hospital Road, Mail Code: R&D 71, indication. In the list, please provide the observational study (e.g., cohort, Portland, OR 97239. ClinicalTrials.gov trial number or, if the case-control, large case series, post trial is not registered, the protocol for FOR FURTHER INFORMATION CONTACT: marketing surveillance) (N ≥ 100). the study including a study number, the Ryan McKenna, Telephone: 503–220– Exclusion 8262 ext. 51723 or Email: SEADS@epc- study period, design, methodology, src.org. indication and diagnosis, proper use All other designs not listed. instructions, inclusion and exclusion SUPPLEMENTARY INFORMATION: The criteria, and primary and secondary Publication Language Agency for Healthcare Research and outcomes. Inclusion Quality has commissioned the D Description of whether the above Evidence-based Practice Centers (EPC) studies constitute ALL Phase II and All KQs: English. Program to complete a review of the above clinical trials sponsored by your Exclusion evidence for Psychological and organization for this indication and an Languages other than English. Pharmacological Treatments for Adults index outlining the relevant information with Posttraumatic Stress Disorder in each submitted file. Sharon B. Arnold, (PTSD): A Systematic Review Update. Your contribution will be very Deputy Director. AHRQ is conducting this systematic beneficial to the EPC Program. Materials [FR Doc. 2017–13395 Filed 6–26–17; 8:45 am] review pursuant to Section 902(a) of the submitted must be publicly available or BILLING CODE 4160–90–P Public Health Service Act, 42 U.S.C. able to be made public. Materials that 299a(a). are considered confidential; marketing The EPC Program is dedicated to materials; study types not included in DEPARTMENT OF HEALTH AND identifying as many studies as possible the review; or information on HUMAN SERVICES that are relevant to the questions for indications not included in the review each of its reviews. In order to do so, we cannot be used by the EPC Program. Agency for Healthcare Research and are supplementing the usual manual This is a voluntary request for Quality and electronic database searches of the information, and all costs for complying literature by requesting information with this request must be borne by the Supplemental Evidence and Data from the public (e.g., details of studies submitter. Request on Psychological and conducted). We are looking for studies The draft of this review will be posted Pharmacological Treatments for Adults that report on Psychological and on AHRQ’s EPC Program Web site and With Posttraumatic Stress Disorder Pharmacological Treatments for Adults available for public comment for a (PTSD): A Systematic Review Update with Posttraumatic Stress Disorder period of 4 weeks. If you would like to mstockstill on DSK30JT082PROD with NOTICES AGENCY: Agency for Healthcare Research (PTSD): A Systematic Review Update, be notified when the draft is posted, and Quality (AHRQ), HHS. including those that describe adverse please sign up for the email list at: ACTION: Request for supplemental events. The entire research protocol, https://www.effectivehealthcare. evidence and data submissions. including the key questions, is also ahrq.gov/index.cfm/join-the- available online at: https:// email-list1/. SUMMARY: The Agency for Healthcare effectivehealthcare.ahrq.gov/index.cfm/ The systematic review will answer the Research and Quality (AHRQ) is seeking search-for-guides-reviews-and-reports/? following questions. This information is VerDate Sep<11>2014 18:33 Jun 26, 2017 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\27JNN1.SGM 27JNN1


Document Created: 2018-11-14 10:14:31
Document Modified: 2018-11-14 10:14:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for supplemental evidence and data submissions.
DatesSubmission Deadline on or before July 27, 2017.
ContactRyan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: [email protected]
FR Citation82 FR 29083 
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