81 FR 62140 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 174 (September 8, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 174 (September 8, 2016)
| Page Range | 62140-62141 | |
| FR Document | 2016-21628 |
[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)] [Notices] [Pages 62140-62141] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21628] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10287] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by November 7, 2016. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for ``Comment or Submission'' or ``More Search Options'' to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number _________, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786- 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES). CMS-10287 Medicare Quality of Care Complaint Form Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before [[Page 62141]] submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Quality of Care Complaint Form; Use: In accordance with Section 1154(a)(14) of the Social Security Act, Quality Improvement Organizations (QIOs) are required to conduct appropriate reviews of all written complaints submitted by beneficiaries concerning the quality of care received. The Medicare Quality of Care Complaint Form will be used by Medicare beneficiaries to submit quality of care complaints. This form will establish a standard form for all beneficiaries to utilize and ensure pertinent information is obtained by QIOs to effectively process these complaints. Form Number: CMS-10287 (OMB control number: 0938-1102); Frequency: Occasionally; Affected Public: Individuals and Households; Number of Respondents: 3,500; Total Annual Responses: 3,500; Total Annual Hours: 583. (For policy questions regarding this collection contact Winsome Higgins at 410-786-1835.) Dated: September 2, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-21628 Filed 9-7-16; 8:45 am] BILLING CODE 4120-01-P
![62140 Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
be developed, or revised, after notice to What You Need to Know,’’ publication consideration, comments and
the public, with a 60-day comment date July 20, 2016. recommendations must be submitted in
period, and in consultation with the With publication of this notice, by any one of the following ways:
Advisory Commission on Childhood November 1, 2016, all health care 1. Electronically. You may send your
Vaccines, appropriate health care providers must discontinue use of the comments electronically to http://
provider and parent organizations, and previous edition of each and provide www.regulations.gov. Follow the
the Food and Drug Administration. The copies of these updated hepatitis A and instructions for ‘‘Comment or
law also requires that the information hepatitis B vaccine information Submission’’ or ‘‘More Search Options’’
contained in the materials be based on materials prior to immunization in to find the information collection
available data and information, be conformance with CDC’s August 9, 2016 document(s) that are accepting
presented in understandable terms, and Instructions for the Use of Vaccine comments.
include: Information Statements. 2. By regular mail. You may mail
(1) A concise description of the written comments to the following
Dated: September 1, 2016.
benefits of the vaccine, address: CMS, Office of Strategic
(2) A concise description of the risks Sandra Cashman,
Operations and Regulatory Affairs,
associated with the vaccine, Executive Secretary, Centers for Disease
Control and Prevention.
Division of Regulations Development,
(3) A statement of the availability of Attention: Document Identifier/OMB
the National Vaccine Injury [FR Doc. 2016–21573 Filed 9–7–16; 8:45 am]
Control Number _________, Room C4–
Compensation Program, and BILLING CODE 4163–18–P
26–05, 7500 Security Boulevard,
(4) Such other relevant information as Baltimore, Maryland 21244–1850.
may be determined by the Secretary. To obtain copies of a supporting
The vaccines initially covered under DEPARTMENT OF HEALTH AND
statement and any related forms for the
the National Vaccine Injury HUMAN SERVICES
proposed collection(s) summarized in
Compensation Program were diphtheria,
Centers for Medicare & Medicaid this notice, you may make your request
tetanus, pertussis, measles, mumps,
Services using one of following:
rubella, and poliomyelitis vaccines.
1. Access CMS’ Web site address at
Since April 15, 1992, any health care [Document Identifier: CMS–10287] http://www.cms.hhs.gov/
provider in the United States who
PaperworkReductionActof1995.
intends to administer one of these Agency Information Collection
2. Email your request, including your
covered vaccines is required to provide Activities: Proposed Collection;
address, phone number, OMB number,
copies of the relevant vaccine Comment Request
and CMS document identifier, to
information materials prior to
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov.
administration of any of these vaccines.
Medicaid Services, HHS. 3. Call the Reports Clearance Office at
Since then, the following vaccines have
ACTION: Notice. (410) 786–1326.
been added to the National Vaccine
Injury Compensation Program, requiring FOR FURTHER INFORMATION CONTACT:
SUMMARY: The Centers for Medicare & Reports Clearance Office at (410) 786–
use of vaccine information materials for
Medicaid Services (CMS) is announcing 1326.
them as well: Hepatitis B, Haemophilus
an opportunity for the public to
influenzae type b (Hib), varicella SUPPLEMENTARY INFORMATION:
comment on CMS’ intention to collect
(chickenpox), pneumococcal conjugate,
information from the public. Under the Contents
rotavirus, hepatitis A, meningococcal,
Paperwork Reduction Act of 1995 (the
human papillomavirus (HPV), and This notice sets out a summary of the
PRA), federal agencies are required to
seasonal influenza vaccines. use and burden associated with the
publish notice in the Federal Register
Instructions for use of the vaccine following information collections. More
concerning each proposed collection of
information materials are found on the detailed information can be found in
information (including each proposed
CDC Web site at: http://www.cdc.gov/ each collection’s supporting statement
extension or reinstatement of an existing
vaccines/hcp/vis/index.html. and associated materials (see
collection of information) and to allow
ADDRESSES).
Revised Vaccine Information Materials 60 days for public comment on the
The hepatitis A and hepatitis B proposed action. Interested persons are CMS–10287 Medicare Quality of Care
vaccine information materials invited to send comments regarding our Complaint Form
referenced in this notice were burden estimates or any other aspect of Under the PRA (44 U.S.C. 3501–
developed in consultation with the this collection of information, including 3520), federal agencies must obtain
Advisory Commission on Childhood any of the following subjects: The approval from the Office of Management
Vaccines, the Food and Drug necessity and utility of the proposed and Budget (OMB) for each collection of
Administration, and parent and information collection for the proper information they conduct or sponsor.
healthcare provider organizations. performance of the agency’s functions; The term ‘‘collection of information’’ is
Following consultation and review of the accuracy of the estimated burden; defined in 44 U.S.C. 3502(3) and 5 CFR
comments submitted, the vaccine ways to enhance the quality, utility, and 1320.3(c) and includes agency requests
information materials covering hepatitis clarity of the information to be or requirements that members of the
A and hepatitis B vaccines have been collected; and the use of automated public submit reports, keep records, or
finalized and are available to download collection techniques or other forms of provide information to a third party.
mstockstill on DSK3G9T082PROD with NOTICES
from http://www.cdc.gov/vaccines/hcp/ information technology to minimize the Section 3506(c)(2)(A) of the PRA
vis/index.html or http:// information collection burden. requires federal agencies to publish a
www.regulations.gov (see Docket DATES: Comments must be received by 60-day notice in the Federal Register
Number CDC–2016–0015). The Vaccine November 7, 2016. concerning each proposed collection of
Information Statements (VIS) are ADDRESSES: When commenting, please information, including each proposed
‘‘Hepatitis A Vaccine: What You Need reference the document identifier or extension or reinstatement of an existing
to Know’’ and ‘‘Hepatitis B Vaccine: OMB control number. To be assured collection of information, before
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![Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices 62141
submitting the collection to OMB for prepared under the auspices of the and Drug Administration, 5630 Fishers
approval. To comply with this International Council for Harmonisation Lane, Rm. 1061, Rockville, MD 20852.
requirement, CMS is publishing this (ICH), formerly the International • For written/paper comments
notice. Conference on Harmonisation. This submitted to the Division of Dockets
question and answer (Q&A) guidance Management, FDA will post your
Information Collection comment, as well as any attachments,
provides additional information to
1. Type of Information Collection facilitate interpretation of the ‘‘S3A except for information submitted,
Request: Extension of a currently Guidance: The Assessment of Systemic marked and identified, as confidential,
approved collection; Title of Exposure in Toxicity Studies’’ (S3A if submitted as detailed in
Information Collection: Medicare guidance), especially to address the ‘‘Instructions.’’
Quality of Care Complaint Form; Use: In benefit and use of microsampling Instructions: All submissions received
accordance with Section 1154(a)(14) of techniques in main study animals. The must include the Docket No. FDA–
the Social Security Act, Quality Q&A guidance is intended to provide 2016–D–2513 for ‘‘ICH S3A Guidance:
Improvement Organizations (QIOs) are points to consider before incorporating Note for Guidance on Toxicokinetics:
required to conduct appropriate reviews the microsampling method in The Assessment of Systemic Exposure
of all written complaints submitted by toxicokinetic studies, and acknowledges in Toxicity Studies—Questions and
beneficiaries concerning the quality of the benefits (and some limitations) of Answers; International Council for
care received. The Medicare Quality of the use of microsampling. Harmonisation; Draft Guidance for
Care Complaint Form will be used by Industry; Availability.’’
DATES: Although you can comment on
Medicare beneficiaries to submit quality Received comments will be placed in
any guidance at any time (see 21 CFR the docket and, except for those
of care complaints. This form will
10.115(g)(5)), to ensure that the Agency submitted as ‘‘Confidential
establish a standard form for all
considers your comment on this draft Submissions,’’ publicly viewable at
beneficiaries to utilize and ensure
guidance before it begins work on the http://www.regulations.gov or at the
pertinent information is obtained by
final version of the guidance, submit Division of Dockets Management
QIOs to effectively process these
either electronic or written comments between 9 a.m. and 4 p.m., Monday
complaints. Form Number: CMS–10287
on the draft guidance by December 7, through Friday.
(OMB control number: 0938–1102);
2016. • Confidential Submissions—To
Frequency: Occasionally; Affected
Public: Individuals and Households; ADDRESSES: You may submit comments submit a comment with confidential
Number of Respondents: 3,500; Total as follows: information that you do not wish to be
Annual Responses: 3,500; Total Annual made publicly available, submit your
Electronic Submissions comments only as a written/paper
Hours: 583. (For policy questions
regarding this collection contact Submit electronic comments in the submission. You should submit two
Winsome Higgins at 410–786–1835.) following way: copies total. One copy will include the
• Federal eRulemaking Portal: http:// information you claim to be confidential
Dated: September 2, 2016. www.regulations.gov. Follow the with a heading or cover note that states
William N. Parham, III, instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
Director, Paperwork Reduction Staff, Office Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The
of Strategic Operations and Regulatory including attachments, to http:// Agency will review this copy, including
Affairs. the claimed confidential information, in
www.regulations.gov will be posted to
[FR Doc. 2016–21628 Filed 9–7–16; 8:45 am] the docket unchanged. Because your its consideration of comments. The
BILLING CODE 4120–01–P comment will be made public, you are second copy, which will have the
solely responsible for ensuring that your claimed confidential information
comment does not include any redacted/blacked out, will be available
DEPARTMENT OF HEALTH AND confidential information that you or a for public viewing and posted on http://
HUMAN SERVICES third party may not wish to be posted, www.regulations.gov. Submit both
Food and Drug Administration such as medical information, your or copies to the Division of Dockets
anyone else’s Social Security number, or Management. If you do not wish your
[Docket No. FDA–2016–D–2513] confidential business information, such name and contact information to be
as a manufacturing process. Please note made publicly available, you can
ICH S3A Guidance: Note for Guidance that if you include your name, contact provide this information on the cover
on Toxicokinetics: The Assessment of information, or other information that sheet and not in the body of your
Systemic Exposure in Toxicity identifies you in the body of your comments and you must identify this
Studies—Questions and Answers; comments, that information will be information as ‘‘confidential.’’ Any
International Council for posted on http://www.regulations.gov. information marked as ‘‘confidential’’
Harmonisation; Draft Guidance for • If you want to submit a comment will not be disclosed except in
Industry; Availability with confidential information that you accordance with 21 CFR 10.20 and other
AGENCY: Food and Drug Administration, do not wish to be made available to the applicable disclosure law. For more
HHS. public, submit the comment as a information about FDA’s posting of
ACTION: Notice. written/paper submission and in the comments to public dockets, see 80 FR
manner detailed (see ‘‘Written/Paper 56469, September 18, 2015, or access
SUMMARY: The Food and Drug the information at: http://www.fda.gov/
mstockstill on DSK3G9T082PROD with NOTICES
Submissions’’ and ‘‘Instructions’’).
Administration (FDA or Agency) is regulatoryinformation/dockets/
announcing the availability of a draft Written/Paper Submissions default.htm.
guidance entitled ‘‘ICH S3A Guidance: Submit written/paper submissions as Docket: For access to the docket to
Note for Guidance on Toxicokinetics: follows: read background documents or the
The Assessment of Systemic Exposure • Mail/Hand delivery/Courier (for electronic and written/paper comments
in Toxicity Studies—Questions and written/paper submissions): Division of received, go to http://
Answers.’’ The draft guidance was Dockets Management (HFA–305), Food www.regulations.gov and insert the
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Document Created: 2018-02-09 13:12:44
Document Modified: 2018-02-09 13:12:44
| 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 must be received by November 7, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 62140 |
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