80 FR 79915 - Agency Information Collection Activities: Proposed Collection; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 246 (December 23, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 246 (December 23, 2015)
| Page Range | 79915-79917 | |
| FR Document | 2015-32171 |
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)] [Notices] [Pages 79915-79917] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32171] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection; Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than February 22, 2016. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 10C-16, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of [[Page 79916]] the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: 340B Drug Pricing Program Reporting Requirements. OMB No. 0915-0176--[Revision]. Abstract: Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act) ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B provides that a manufacturer who participates in Medicaid must sign a Pharmaceutical Pricing Agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge enrolled covered entities a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities who choose to participate in the section 340B Drug Pricing Program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from requesting Medicaid reimbursement from a drug that has been discounted under the 340B Program. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity. Section 340B(a)(5)(C) of the PHS Act permits the Secretary and manufacturers of a covered outpatient drug to conduct audits of covered entities in accordance with procedures established by the Secretary related to the number, duration and scope of the audits. Manufacturers are permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. The manufacturer notifies the covered entity in writing when it believes the covered entity has violated these provisions of the 340B Program. If the problem cannot be resolved, the manufacturer will then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to the HRSA Office of Pharmacy Affairs (OPA) for review. OPA will review the documentation to determine if reasonable cause exists. Once the audit is completed, the manufacturer will submit copies of the audit report to OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the HHS Office of Inspector General (OIG). In response to the statutory mandate of section 340B(a)(5)(C) to permit the Secretary or manufacturers to conduct audits of covered entities and because of the potential for disputes involving covered entities and participating drug manufacturers, OPA developed an informal voluntary dispute resolution process for manufacturers and covered entities, who prior to filing a request for resolution of a dispute with OPA, should attempt in good faith to resolve the dispute. All parties involved in the dispute must maintain written documentation as evidence of a good faith attempt to resolve the dispute. If the dispute is not resolved and dispute resolution is desired, a party must submit a written request for a review of the dispute to OPA. A committee appointed to review the documentation will send a letter to the party alleged to have committed a violation. The party will be asked to provide a response to or a rebuttal of the allegations. HRSA published a Notice in 1996 and a policy release in 2011 on manufacturer audit guidelines and the informal dispute resolution process. (61 FR 65406 (December 12, 1996) and ``Clarification of Manufacturer Audits of 340B Covered Entities,'' Release No. 2011-3). The expected revision to this package includes additional background information on the dispute resolution process and clarifies the need and proposed use of information regarding the manufacturer audit guidelines and the informal dispute resolution process. Need and Proposed Use of the Information: HRSA is proposing the collection of information related to the manufacturer audit guidelines. These guidelines contain the following reporting/notification elements: 1. Manufacturers should notify the entity in writing when it believes a violation has occurred; 2. Manufacturers should submit documentation to OPA as evidence of good faith of attempts to resolve a dispute. 3. Manufacturers must submit an audit work plan to OPA; 4. Manufacturers should submit the audit report to the OPA and informational copies to the HHS OIG; and 5. The covered entity should provide a written response to the audit report. This information is necessary to ensure the orderly conduct of manufacturer audits. In addition, the informal dispute resolution process requires the participating manufacturer or covered entity requesting dispute resolution to provide OPA with a written request. The party alleged to have committed a section 340B violation, may provide a response or rebuttal to OPA. This information is necessary in order to ensure that the dispute will be resolved in a fair and equitable manner. Likely Respondents: Drug manufacturers and 340B covered entities. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested during an audit. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information for both covered entities and manufacturers. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Number of responses per Total per response Total burden respondents respondent responses (in hours) hours ---------------------------------------------------------------------------------------------------------------- AUDITS: Good faith Resolution \1\... 10 1 10 40 400 Audit Notification to Entity 10 1 10 4 40 \1\........................ Audit Workplan \1\.......... 40 1 18 8 144 [[Page 79917]] Audit Report \1\............ 8 1 8 8 64 Entity Response............. 8 1 8 8 64 DISPUTE RESOLUTION: Dispute Request............. 10 4 40 10 400 Rebuttal.................... 10 1 10 16 160 ------------------------------------------------------------------------------- Total................... 96 .............. 104 .............. 1272 ---------------------------------------------------------------------------------------------------------------- \1\ Prepared by the manufacturer. Recordkeeping Burden ------------------------------------------------------------------------ Number of Hours of Total Recordkeeping requirement recordkeepers recordkeeping burden ------------------------------------------------------------------------ Dispute Records................ 50 0.5 25 ------------------------------------------------------------------------ HRSA specifically requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-32171 Filed 12-22-15; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices 79915
recent studies conducted by the Public factors. In addition, FDA made the Budget (OMB) under the Paperwork
Health Service and revised the guidance following changes to clarify certain Reduction Act of 1995 (44 U.S.C. 3501–
accordingly. FDA considered several recommendations in the guidance, 3520). The collections of information in
options to address the comments in which are consistent with current 21 CFR 601.12 have been approved
response to the revised MSM donor policy: (1) Clarified that donors who under OMB control number 0910–0338;
deferral policy. Because evidence have been determined to have a false- the collections of information in 21 CFR
indicates that the indefinite deferral positive HIV test may be reentered 606.171 have been approved under
policy for MSM may have become less according to a requalification method OMB control number 0910–0458; and
effective over time, FDA has determined found acceptable to FDA; (2) noted that the collections of information in 21 CFR
that a change in policy is warranted at recipients of allogeneic blood 610.46, 630.6, 640.3 and 640.63 have
this time. Data on the limitations of transfusions (i.e., not autologous been approved under OMB control
nucleic acid tests to identify antibody transfusions), should be temporarily number 0910–0116.
negative window period HIV infections deferred; (3) provided reference to an
FDA guidance on the collection of blood III. Electronic Access
suggests that donor testing alone, absent
any deferral for MSM, would result in components from donors at risk of HIV Persons with access to the Internet
an unacceptable increased risk of infection; and (4) clarified the deferral may obtain the guidance at either
transfusion-transmitted HIV. Similarly, by the responsible physician of a blood http://www.fda.gov/BiologicsBlood
pretesting at risk donors with a rapid establishment of any donor if the Vaccines/GuidanceCompliance
HIV test prior to donation would be donation could affect the health of the RegulatoryInformation/Guidances/
logistically challenging and would not donor or the safety of the blood default.htm or http://
necessarily identify newly HIV-infected component. Additionally, the www.regulations.gov.
individuals. While individual donor background section has been expanded Dated: December 17, 2015.
assessment for risk has been to summarize FDA’s evaluation of the
Leslie Kux,
implemented in a few countries, the available policy options under the
available evidence relevant to the MSM Associate Commissioner for Policy.
implementation of this strategy in the
deferral policy. Minor editorial changes [FR Doc. 2015–32250 Filed 12–22–15; 8:45 am]
United States would present significant
practical challenges and currently there have also been made to the guidance. BILLING CODE 4164–01–P
is no validated and accepted individual FDA remains committed to exploring
risk assessment tool or questionnaire. options and engaging in public
discussions regarding enhancements to DEPARTMENT OF HEALTH AND
Therefore, FDA concluded a time-based HUMAN SERVICES
deferral for history of male-male sex is donor and public education regarding
the most appropriate policy to maintain safe blood donors and evaluating the
effectiveness of the donor history Health Resources and Services
the safety of the U.S. blood supply. Administration
Scientific data regarding the questionnaire. Further, with the
effectiveness of a 1-year deferral in implementation of a transfusion Agency Information Collection
Australia, a country with similar HIV transmitted infectious disease Activities: Proposed Collection; Public
epidemiology to the United States, monitoring system, FDA will be able to Comment Request
supports FDA’s policy change to the monitor donor risk factors and the safety
blood donor deferral period for MSM of the blood supply, as well as AGENCY: Health Resources and Services
from indefinite deferral to 1 year since investigate and refine blood safety Administration, HHS.
the last sexual contact. Scientifically measures in the future. FDA’s ACTION: Notice.
robust data are not available for time- recommendations may evolve over time
as new scientific data become available SUMMARY: In compliance with the
based deferrals of less than 1 year. FDA
on strategies to maintain or improve requirement for opportunity for public
also concluded that scientific data are
blood safety. comment on proposed data collection
not currently available that would
The guidance announced in this projects (Section 3506(c)(2)(A) of the
support revisions to the indefinite
notice finalizes the draft guidance dated Paperwork Reduction Act of 1995), the
deferral policy for commercial sex
May 2015 and supersedes the 1992 Health Resources and Services
workers or intravenous drug users.
blood memo. Administration (HRSA) announces
In response to comments, FDA made This guidance is being issued plans to submit an Information
the following changes when finalizing consistent with FDA’s good guidance Collection Request (ICR), described
the guidance: (1) Amended the practices regulation (21 CFR 10.115). below, to the Office of Management and
recommendations regarding the The guidance represents the current Budget (OMB). Prior to submitting the
inclusion of signs and symptoms thinking of FDA on recommendations ICR to OMB, HRSA seeks comments
associated with HIV in the donor for reducing the risk of HIV from the public regarding the burden
educational materials; (2) revised the transmission by blood and blood estimate, below, or any other aspect of
recommendation for the deferral of products. It does not establish any rights the ICR.
female donors who have had sex with for any person and is not binding on DATES: Comments on this ICR should be
MSM; (3) stated that FDA no longer FDA or the public. You can use an received no later than February 22,
recommends deferral for individuals alternative approach if it satisfies the 2016.
who have had sex with an individual requirements of the applicable statutes
with hemophilia or related clotting and regulations. ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
tkelley on DSK3SPTVN1PROD with NOTICES
deficiencies requiring treatment with
clotting factor concentrates; and (4) II. Paperwork Reduction Act of 1995 Information Collection Clearance
revised the recommendations regarding The guidance refers to previously Officer, Room 10C–16, 5600 Fishers
product retrieval and consignee approved collections of information Lane, Rockville, MD 20857.
notification of distributed blood found in FDA regulations. These FOR FURTHER INFORMATION CONTACT: To
products collected from a donor who collections of information are subject to request more information on the
should have been deferred for HIV risk review by the Office of Management and proposed project or to obtain a copy of
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![79916 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices
the data collection plans and draft work plan describing the audit and guidelines contain the following
instruments, email paperwork@hrsa.gov evidence in support of the reasonable reporting/notification elements:
or call the HRSA Information Collection cause standard to the HRSA Office of 1. Manufacturers should notify the
Clearance Officer at (301) 443–1984. Pharmacy Affairs (OPA) for review. entity in writing when it believes a
SUPPLEMENTARY INFORMATION: When OPA will review the documentation to violation has occurred;
submitting comments or requesting determine if reasonable cause exists. 2. Manufacturers should submit
information, please include the Once the audit is completed, the documentation to OPA as evidence of
information request collection title for manufacturer will submit copies of the good faith of attempts to resolve a
reference. audit report to OPA for review and dispute.
Information Collection Request Title: resolution of the findings, as
340B Drug Pricing Program Reporting appropriate. The manufacturer will also 3. Manufacturers must submit an
Requirements. submit an informational copy of the audit work plan to OPA;
OMB No. 0915–0176—[Revision]. audit report to the HHS Office of 4. Manufacturers should submit the
Abstract: Section 602 of Public Law Inspector General (OIG). audit report to the OPA and
102–585, the Veterans Health Care Act In response to the statutory mandate informational copies to the HHS OIG;
of 1992, enacted section 340B of the of section 340B(a)(5)(C) to permit the and
Public Health Service Act (PHS Act) Secretary or manufacturers to conduct 5. The covered entity should provide
‘‘Limitation on Prices of Drugs audits of covered entities and because of a written response to the audit report.
Purchased by Covered Entities.’’ Section the potential for disputes involving This information is necessary to
340B provides that a manufacturer who covered entities and participating drug ensure the orderly conduct of
participates in Medicaid must sign a manufacturers, OPA developed an manufacturer audits. In addition, the
Pharmaceutical Pricing Agreement with informal voluntary dispute resolution informal dispute resolution process
the Secretary of Health and Human process for manufacturers and covered requires the participating manufacturer
Services in which the manufacturer entities, who prior to filing a request for or covered entity requesting dispute
agrees to charge enrolled covered resolution of a dispute with OPA, resolution to provide OPA with a
entities a price for covered outpatient should attempt in good faith to resolve written request. The party alleged to
drugs that will not exceed an amount the dispute. All parties involved in the have committed a section 340B
determined under a statutory formula. dispute must maintain written violation, may provide a response or
Covered entities who choose to documentation as evidence of a good rebuttal to OPA. This information is
participate in the section 340B Drug faith attempt to resolve the dispute. If necessary in order to ensure that the
Pricing Program must comply with the the dispute is not resolved and dispute dispute will be resolved in a fair and
requirements of 340B(a)(5) of the PHS resolution is desired, a party must equitable manner.
Act. Section 340B(a)(5)(A) prohibits a submit a written request for a review of
covered entity from requesting Medicaid the dispute to OPA. A committee Likely Respondents: Drug
reimbursement from a drug that has appointed to review the documentation manufacturers and 340B covered
been discounted under the 340B will send a letter to the party alleged to entities.
Program. Further, section 340B(a)(5)(B) have committed a violation. The party Burden Statement: Burden in this
prohibits a covered entity from reselling will be asked to provide a response to context means the time expended by
or otherwise transferring a discounted or a rebuttal of the allegations. persons to generate, maintain, retain,
drug to a person who is not a patient of HRSA published a Notice in 1996 and disclose or provide the information
the entity. a policy release in 2011 on requested during an audit. This includes
Section 340B(a)(5)(C) of the PHS Act manufacturer audit guidelines and the the time needed to review instructions;
permits the Secretary and manufacturers informal dispute resolution process. (61 to develop, acquire, install, and utilize
of a covered outpatient drug to conduct FR 65406 (December 12, 1996) and technology and systems for the purpose
audits of covered entities in accordance ‘‘Clarification of Manufacturer Audits of of collecting, validating and verifying
with procedures established by the 340B Covered Entities,’’ Release No. information, processing and
Secretary related to the number, 2011–3). maintaining information, and disclosing
duration and scope of the audits. The expected revision to this package and providing information; to train
Manufacturers are permitted to includes additional background personnel and to be able to respond to
conduct an audit only when there is information on the dispute resolution a collection of information; to search
reasonable cause to believe a violation process and clarifies the need and data sources, to complete and review
of section 340B(a)(5)(A) or (B) has proposed use of information regarding the collection of information; and to
occurred. The manufacturer notifies the the manufacturer audit guidelines and transmit or otherwise disclose the
covered entity in writing when it the informal dispute resolution process. information for both covered entities
believes the covered entity has violated Need and Proposed Use of the and manufacturers. The total annual
these provisions of the 340B Program. If Information: HRSA is proposing the burden hours estimated for this
the problem cannot be resolved, the collection of information related to the Information Collection Request are
manufacturer will then submit an audit manufacturer audit guidelines. These summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total burden
tkelley on DSK3SPTVN1PROD with NOTICES
Form name responses per
respondents responses response hours
respondent (in hours)
AUDITS:
Good faith Resolution 1 ................................................. 10 1 10 40 400
Audit Notification to Entity 1 .......................................... 10 1 10 4 40
Audit Workplan 1 ........................................................... 40 1 18 8 144
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TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Audit Report 1 ................................................................ 8 1 8 8 64
Entity Response ............................................................ 8 1 8 8 64
DISPUTE RESOLUTION:
Dispute Request ........................................................... 10 4 40 10 400
Rebuttal ......................................................................... 10 1 10 16 160
Total ....................................................................... 96 ........................ 104 ........................ 1272
1 Prepared by the manufacturer.
RECORDKEEPING BURDEN comment on proposed data collection consists of information that the agency
projects (Section 3506(c)(2)(A) of the is required to obtain to comply with the
Record- Number Hours of Paperwork Reduction Act of 1995), the National Environmental Policy Act of
keeping Total Health Resources and Services 1969 (NEPA). NEPA establishes the
of record- record-
require- burden
ment keepers keeping Administration (HRSA) announces federal government’s national policy for
plans to submit an Information protection of the environment. HRSA
Dispute Collection Request (ICR), described has developed the EID for applicants of
Recor- below, to the Office of Management and funding that would potentially impact
ds ...... 50 0.5 25 Budget (OMB). Prior to submitting the the environment and to ensure that their
ICR to OMB, HRSA seeks comments decision-making processes are
HRSA specifically requests comments from the public regarding the burden consistent with NEPA.
on: (1) The necessity and utility of the estimate, below, or any other aspect of Need and Proposed Use of the
proposed information collection for the the ICR. Information: Applicants must provide
proper performance of the agency’s DATES: Comments on this Information information and assurance of
functions, (2) the accuracy of the Collection Request must be received no compliance with NEPA on the EID
estimated burden, (3) ways to enhance later than February 22, 2016. checklist. This information is reviewed
the quality, utility, and clarity of the ADDRESSES: Submit your comments to in the Pre-Award stage.
information to be collected, and (4) the paperwork@hrsa.gov or mail the HRSA Likely Respondents: HRSA applicants
use of automated collection techniques Information Collection Clearance applying for federal construction grants
or other forms of information Officer, Room 10–29, Parklawn and cooperative agreements.
technology to minimize the information Building, 5600 Fishers Lane, Rockville, Burden Statement: Burden in this
collection burden. MD 20857. context means the time expended by
Jackie Painter, FOR FURTHER INFORMATION CONTACT: To persons to generate, maintain, retain,
Director, Division of the Executive Secretariat. request more information on the disclose, or provide the information
[FR Doc. 2015–32171 Filed 12–22–15; 8:45 am] proposed project or to obtain a copy of requested. This includes the time
BILLING CODE 4165–15–P the data collection plans and draft needed to review instructions; to
instruments, email paperwork@hrsa.gov develop, acquire, install, and utilize
or call the HRSA Information Collection technology and systems for the purpose
DEPARTMENT OF HEALTH AND Clearance Officer at (301) 443–1984. of collecting, validating and verifying
HUMAN SERVICES SUPPLEMENTARY INFORMATION: When information, processing and
submitting comments or requesting maintaining information, and disclosing
Health Resources and Services information, please include the and providing information; to train
Administration information request collection title for personnel and to be able to respond to
reference. a collection of information; to search
Agency Information Collection Information Collection Request Title: data sources; to complete and review
Activities: Proposed Collection: Public HRSA National Environmental Policy the collection of information; and to
Comment Request Act (NEPA) Environmental Information transmit or otherwise disclose the
AGENCY: Health Resources and Services and Documentation (EID) OMB No. information. The total annual burden
Administration, HHS. 0915–0324—Extension. hours estimated for this Information
ACTION: Notice. Abstract: HRSA is requesting Collection Request are summarized in
extension of the approval for the the table below.
SUMMARY: In compliance with the Environmental Information and Total Estimated Annualized burden
requirement for opportunity for public Documentation (EID) checklist which hours:
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent
tkelley on DSK3SPTVN1PROD with NOTICES
(in hours)
NEPA EID Checklist ............................................................ 1,350 1 1,350 1.0 1,350
Total .............................................................................. 1,350 1 1,350 1.0 1,350
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Document Created: 2018-03-02 09:21:09
Document Modified: 2018-03-02 09:21:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than February 22, 2016. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 80 FR 79915 |
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