Agency Information Collection Activities: Proposed Collection; Comment Request, 58354-58355 [2014-23132]

Download as PDF 58354 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices representation of both genders, ethnic and racial minorities, and persons with disabilities. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items: • Current curriculum vitae, including complete contact information (name, affiliation, mailing address, telephone number, email address) • A letter of recommendation stating the qualifications of the candidate Nomination materials must be postmarked by October 24, 2014, and sent to: Kim Distel, Office of Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop D10, Atlanta, Georgia 30333, telephone (404) 639–2100. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry. Claudette Grant, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2014–23055 Filed 9–26–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10492] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. ACTION: Notice. AGENCY: 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 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:44 Sep 26, 2014 Jkt 232001 this collection of information, including any of the following subjects: (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. Comments must be received by November 28, 2014: ADDRESSES: When commenting, please reference the document identifier or OMB control number (OCN). 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 Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. DATES: 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–10492 Data PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Submission for the Federally-faciliated Exchange User Fee Adjustment 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 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: New collection (Request for a new OMB control number); Title of Information Collection: Data Submission for the Federally-facilitated Exchange User Fee Adjustment; Use: The final rule ‘‘Coverage of Certain Preventive Services Under the Affordable Care Act’’ published by the Departments of Health and Human Services (HHS), the Treasury, and Labor on July 2, 2013 (78 FR 39870), sets forth regulations regarding coverage for certain preventive services under section 2713 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the Public Health Service Act requires coverage without cost sharing of certain preventive health services, including certain contraceptive services, in non-exempt, nongrandfathered group health plans and health insurance coverage. The final rules establish accommodations with respect to group health plans established or maintained by eligible organizations (and group health insurance coverage offered in connection with such plans). Eligible organizations are required to self-certify that they are eligible for this accommodation and provide a copy of such self-certification to their third party administrators. The final rules also set forth processes and standards to fund the payments for the contraceptive services that are provided for participants and beneficiaries in selfinsured plans of eligible organizations E:\FR\FM\29SEN1.SGM 29SEN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices under the accommodation described previously, through an adjustment in the Federally-facilitated Exchange (FFE) user fee payable by an issuer participating in an FFE. In order to facilitate the FFE user fee adjustment, and ensure that these user fee adjustments reflect payments for contraceptive services provided under this accommodation and that the adjustment is applied to the appropriate participating issuer in an FFE, the final rule requires an information collection from applicable participating issuers and third party administrators. In particular, the final regulations at 45 CFR 156.50(d)(2)(i) provide that a participating issuer who seeks an FFE user fee adjustment must submit to HHS in the year following the benefit year in which payments for contraceptive services were made under the previously mentioned accommodation, identifying information for the participating issuer, each third party administrator, and each self-insured group health plan, as well as the total dollar amount of the payments for contraceptive services that were provided during the applicable calendar year under the accommodation. The final regulation at 45 CFR 156.50(d)(2)(iii) also requires the third party administrator to submit to HHS identifying information for the third party administrator, the participating issuer, and each self-insured group health plan, as well as the total number of participants and beneficiaries in each self-insured group health plan during the applicable calendar year, the total dollar amount of payments made for contraceptive services, and an attestation that the payments for contraceptive services were made in compliance with 26 CFR 54.9815– 2713A(b)(2) or 29 CFR 2590.715– 2713A(b)(2). Furthermore, to determine the potential number of submissions provided by third party administrators and allow HHS to prepare to receive submissions in calendar year 2015, the final regulation at 45 CFR 156.50(d)(2)(ii) requires third party administrators to submit to HHS a notification that the third party administrator intends for a participating issuer to seek an FFE user fee adjustment, by the later of January 1, 2014, or the 60th calendar day following the date on which the third party administrator receives a copy of a selfcertification from an eligible organization. Additionally, a health insurance issuer providing payments for contraceptive services for participants and beneficiaries in insured plans (or student enrollees and covered VerDate Sep<11>2014 16:44 Sep 26, 2014 Jkt 232001 dependents in student health insurance coverage) of eligible organizations to provide a written notice to such plan participants and beneficiaries (or such student enrollees and covered dependents) informing them of the availability of such payments. The burden associated with these processes includes the time for applicable participating issuers and third party administrators to submit identifying information and total payments made for contraceptive services in the prior calendar year, and for third party administrators to notify HHS of their intent to seek the user fee adjustment. HHS estimates 488 third party administrators, 48 QHP issuers, and 325 fully insured issuers of eligible organizations will submit this information. HHS anticipates that participating issuers in an FFE seeking a user fee adjustment and third party administrators with respect to which the FFE user fee adjustment is received will submit this information electronically. Form Number: CMS–10492 (OMB Control Number: 0938–NEW); Frequency: Once, Yearly. Affected Public: Private Sector—Business or other for-profits and Not-for-profit institutions; Number of Respondents: 861; Total Annual Responses: 861 Total Annual Hours: 12,930. (For policy questions regarding this collection contact Jaya Ghildiyal at (301) 492– 5149.) Dated: September 24, 2014. Martique Jones, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2014–23132 Filed 9–26–14; 8:45 am] BILLING CODE 4120–01–U–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1409] Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 58355 PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on adverse event reporting by FDA on new animal drugs and product/ manufacturing defects collected on paper forms. DATES: Submit either electronic or written comments on the collection of information by November 28, 2014. ADDRESSES: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: 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. ‘‘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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Pages 58354-58355]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10492]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

ACTION: Notice.

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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: (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.

DATES: Comments must be received by November 28, 2014:

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number (OCN). 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 Paperwork@cms.hhs.gov.
    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-10492 Data Submission for the Federally-
faciliated Exchange User Fee Adjustment
    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 
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: New collection (Request 
for a new OMB control number); Title of Information Collection: Data 
Submission for the Federally-facilitated Exchange User Fee Adjustment; 
Use: The final rule ``Coverage of Certain Preventive Services Under the 
Affordable Care Act'' published by the Departments of Health and Human 
Services (HHS), the Treasury, and Labor on July 2, 2013 (78 FR 39870), 
sets forth regulations regarding coverage for certain preventive 
services under section 2713 of the Public Health Service Act, as added 
by the Patient Protection and Affordable Care Act, as amended, and 
incorporated into the Employee Retirement Income Security Act of 1974 
and the Internal Revenue Code. Section 2713 of the Public Health 
Service Act requires coverage without cost sharing of certain 
preventive health services, including certain contraceptive services, 
in non-exempt, non-grandfathered group health plans and health 
insurance coverage. The final rules establish accommodations with 
respect to group health plans established or maintained by eligible 
organizations (and group health insurance coverage offered in 
connection with such plans). Eligible organizations are required to 
self-certify that they are eligible for this accommodation and provide 
a copy of such self-certification to their third party administrators. 
The final rules also set forth processes and standards to fund the 
payments for the contraceptive services that are provided for 
participants and beneficiaries in self-insured plans of eligible 
organizations

[[Page 58355]]

under the accommodation described previously, through an adjustment in 
the Federally-facilitated Exchange (FFE) user fee payable by an issuer 
participating in an FFE.
    In order to facilitate the FFE user fee adjustment, and ensure that 
these user fee adjustments reflect payments for contraceptive services 
provided under this accommodation and that the adjustment is applied to 
the appropriate participating issuer in an FFE, the final rule requires 
an information collection from applicable participating issuers and 
third party administrators. In particular, the final regulations at 45 
CFR 156.50(d)(2)(i) provide that a participating issuer who seeks an 
FFE user fee adjustment must submit to HHS in the year following the 
benefit year in which payments for contraceptive services were made 
under the previously mentioned accommodation, identifying information 
for the participating issuer, each third party administrator, and each 
self-insured group health plan, as well as the total dollar amount of 
the payments for contraceptive services that were provided during the 
applicable calendar year under the accommodation. The final regulation 
at 45 CFR 156.50(d)(2)(iii) also requires the third party administrator 
to submit to HHS identifying information for the third party 
administrator, the participating issuer, and each self-insured group 
health plan, as well as the total number of participants and 
beneficiaries in each self-insured group health plan during the 
applicable calendar year, the total dollar amount of payments made for 
contraceptive services, and an attestation that the payments for 
contraceptive services were made in compliance with 26 CFR 54.9815-
2713A(b)(2) or 29 CFR 2590.715-2713A(b)(2).
    Furthermore, to determine the potential number of submissions 
provided by third party administrators and allow HHS to prepare to 
receive submissions in calendar year 2015, the final regulation at 45 
CFR 156.50(d)(2)(ii) requires third party administrators to submit to 
HHS a notification that the third party administrator intends for a 
participating issuer to seek an FFE user fee adjustment, by the later 
of January 1, 2014, or the 60th calendar day following the date on 
which the third party administrator receives a copy of a self-
certification from an eligible organization. Additionally, a health 
insurance issuer providing payments for contraceptive services for 
participants and beneficiaries in insured plans (or student enrollees 
and covered dependents in student health insurance coverage) of 
eligible organizations to provide a written notice to such plan 
participants and beneficiaries (or such student enrollees and covered 
dependents) informing them of the availability of such payments.
    The burden associated with these processes includes the time for 
applicable participating issuers and third party administrators to 
submit identifying information and total payments made for 
contraceptive services in the prior calendar year, and for third party 
administrators to notify HHS of their intent to seek the user fee 
adjustment. HHS estimates 488 third party administrators, 48 QHP 
issuers, and 325 fully insured issuers of eligible organizations will 
submit this information. HHS anticipates that participating issuers in 
an FFE seeking a user fee adjustment and third party administrators 
with respect to which the FFE user fee adjustment is received will 
submit this information electronically. Form Number: CMS-10492 (OMB 
Control Number: 0938-NEW); Frequency: Once, Yearly. Affected Public: 
Private Sector--Business or other for-profits and Not-for-profit 
institutions; Number of Respondents: 861; Total Annual Responses: 861 
Total Annual Hours: 12,930. (For policy questions regarding this 
collection contact Jaya Ghildiyal at (301) 492-5149.)

    Dated: September 24, 2014.
Martique Jones,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2014-23132 Filed 9-26-14; 8:45 am]
BILLING CODE 4120-01-U-P