83 FR 63179 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 235 (December 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 235 (December 7, 2018)
| Page Range | 63179-63182 | |
| FR Document | 2018-26556 |
[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)] [Notices] [Pages 63179-63182] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26556] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0961] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 7, 2019. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0322. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD [[Page 63180]] 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Environmental Impact Considerations OMB Control Number 0910-0322--Extension I. Background FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information ``Environmental Impact Considerations.'' The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal Agency the duty to consider the environmental effects of its actions. Section 102(2)(C) of NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment. FDA's NEPA regulations are in part 25 (21 CFR part 25). All applications or petitions requesting Agency action require the submission of a claim for categorical exclusion or an environmental assessment (EA). A categorical exclusion applies to certain classes of FDA-regulated actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS. Section 25.15(a) and (d) specifies the procedures for submitting to FDA a claim for a categorical exclusion. Extraordinary circumstances (Sec. 25.21), which may result in significant environmental impacts, may exist for some actions that are usually categorically excluded. An EA provides information that is used to determine whether an FDA action could result in a significant environmental impact. Section 25.40(a) and (c) specifies the content requirements for EAs for non-excluded actions. This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse events cannot be avoided, the Agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a Federal Register document also filed for comment at the Environmental Protection Agency. The final EIS, including the comments received, is reviewed by the Agency to weigh environmental costs and benefits in determining whether to pursue the proposed action or some alternative that would reduce expected environmental impact. Any final EIS would contain additional information gathered by the Agency after the publication of the draft EIS, a copy or a summary of the comments received on the draft EIS, and the Agency's responses to the comments, including any revisions resulting from the comments or other information. When the Agency finds that no significant environmental effects are expected, the Agency prepares a finding of no significant impact. In the Federal Register of June 7, 2018 (83 FR 26477), FDA published a 60-day notice requesting public comment on the proposed collection of information. One PRA related comment was received. (Comment) One commenter requested that FDA should categorically exclude all categories of SE applications from the EA requirement. (Response) FDA appreciates this comment. We note, however, that any action to establish a categorial exclusion would need to be undertaken through a notice and comment rulemaking procedure. FDA estimates the burden of this collection of information as follows: II. Estimated Annual Reporting Burden for Human Drugs (Including Biologics in the Center for Drug Evaluation and Research) Under Sec. Sec. 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i)), each investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) must contain a claim for categorical exclusion under Sec. 25.30 or Sec. 25.31, or an EA under Sec. 25.40. Annually, FDA receives approximately 3,687 INDs from 2,456 sponsors; 140 NDAs from 116 applicants; 3,192 supplements to NDAs from 443 applicants; 28 biologic license applications (BLAs) from 22 applicants; 464 supplements to BLAs from 52 applicants; 1,152 ANDAs from 248 applicants; and 6,774 supplements to ANDAs from 384 applicants. FDA estimates that it receives approximately 15,437 claims for categorical exclusions as required under Sec. 25.15(a) and (d) and 10 EAs as required under Sec. 25.40(a) and (c). Based on information provided by the pharmaceutical industry, FDA estimates that it takes sponsors or applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 3,400 hours to prepare an EA. Table 1--Estimated Annual Reporting Burden for Human Drugs \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 25.15(a) and (d)................ 3,724 4.1453 15,437 8 123,496 25.40(a) and (c)................ 10 1 10 3,400 34,000 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 157,496 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. III. Estimated Annual Reporting Burden for Medical Devices Under Sec. 814.20(b)(11) (21 CFR 814.20(b)(11)), premarket approvals (PMAs) (original PMAs and supplements) must contain a claim for categorical exclusion under Sec. 25.30 or Sec. 25.34 or an EA under Sec. 25.40. In 2017, FDA received an average of 50 claims (original PMAs and supplements) for categorical exclusions as required under Sec. 25.15(a) and (d), and 0 EAs as required under Sec. 25.40(a) and (c). FDA estimates that approximately 50 respondents will submit an average of 1 application for [[Page 63181]] categorical exclusion annually. Based on information provided by sponsors, FDA estimates that it takes approximately 6 hours to prepare a claim for a categorical exclusion. Table 2--Estimated Annual Reporting Burden for Medical Devices \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 25.15(a) and (d)................ 50 1 50 6 300 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. IV. Estimated Annual Reporting Burden for Biological Products, Drugs, and Medical Devices in the Center for Biologics Evaluation and Research Under 21 CFR 601.2(a), BLAs as well as INDs (Sec. 312.23), NDAs (Sec. 314.50), ANDAs (Sec. 314.94), and PMAs (Sec. 814.20) must contain either a claim of categorical exclusion under Sec. 25.30 or Sec. 25.32 or an EA under Sec. 25.40. Annually, FDA receives approximately 34 BLAs from 18 applicants, 801 BLA supplements to license applications from 156 applicants, 345 INDs from 256 sponsors, 1 NDA from 1 applicant, 26 supplements to NDAs from 8 applicants, 1 ANDA from 1 applicant, 1 supplement to ANDAs from 1 applicant, 8 PMAs from 3 applicants, and 33 PMA supplements from 16 applicants. FDA estimates that approximately 10 percent of these supplements would be submitted with a claim for categorical exclusion or an EA. FDA has received approximately 481 claims for categorical exclusion as required under Sec. 25.15(a) and (d) annually and 2 EAs as required under Sec. 25.40(a) and (c) annually. Therefore, FDA estimates that approximately 247 respondents will submit an average of 2 applications for categorical exclusion and 2 respondents will submit an average of 1 EA. Based on information provided by industry, FDA estimates that it takes sponsors and applicants approximately 8 hours to prepare a claim of categorical exclusion and approximately 3,400 hours to prepare an EA for a biological product. Table 3--Estimated Annual Reporting Burden for Biological Products \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 25.15(a) and (d)................ 247 2 494 8 3,952 25.40(a) and (c)................ 2 1 2 3,400 6,800 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 10,752 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. V. Estimated Annual Reporting Burden for Animal Drugs Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1) supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new animal drug applications (INADs) and generic investigational new animal drug applications (JINADs), and 21 CFR 571.1(c) food additive petitions must contain a claim for categorical exclusion under Sec. 25.30 or Sec. 25.32 or an EA under Sec. 25.40. Annually, FDA's Center for Veterinary Medicine has received approximately 810 claims for categorical exclusion as required under Sec. 25.15(a) and (d) and 22 EAs as required under Sec. 25.40(a) and (c). Assuming an average of 10 claims per respondent, FDA estimates that approximately 81 respondents will submit an average of 10 claims for categorical exclusion. FDA further estimates that 22 respondents will submit an average of 1 EA. FDA estimates that it takes sponsors/applicants approximately 3 hours to prepare a claim of categorical exclusion and an average of 2,160 hours to prepare an EA. Table 4--Estimated Annual Reporting Burden for Animal Drugs \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 25.15(a) and (d)................ 81 10 810 3 2,430 25.40(a) and (c)................ 22 1 22 2,160 47,520 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 49,950 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. VI. Estimated Annual Reporting Burden for Tobacco Products Under sections 905, 910, and 911 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387e, 387j, and 387k), product applications and supplements (PMTAs), SEs, Exemption from SEs, and modified risk tobacco products must contain a claim for categorical exclusion or an EA. After further review, the agency has concluded that the majority of the EA burden for tobacco products [[Page 63182]] is covered under already existing information collections. To avoid double counting, the agency has removed the burden which is approved under other FDA information collections. The burden for SEs are currently approved under OMB control number 0910-0673; the burden for PMTAs are currently approved under OMB control number 0910-0768; the burden for SE exemptions are currently approved under OMB control number 0910-0684. FDA's estimates are based on actual report data from fiscal year (FY) 2015 to FY 2017, on average FDA estimated it received approximately 27 modified risk tobacco product applications (MRTPAs) from 27 respondents. Based on updated data for this collection, FDA estimates 27 EAs from 27 respondents. A total of 27 respondents will submit an average of 1 application for environmental assessment. Based on FDA's experience, previous information provided by potential sponsors and knowledge that part of the EA information has already been produced in one of the tobacco product applications, FDA estimates that it takes approximately 80 hours to prepare an EA. Table 5--Estimated Annual Reporting Burden for Tobacco Products \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 25.40(a) and (c)................ 27 1 27 80 2,160 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The Estimated Annual Reporting Burden for Human Foods is no longer a part of this information collection. The burden has now been incorporated into OMB control number 0910-0541. Our estimated burden for the information collection reflects an overall decrease of 10,566 hours (currently approved 231,224) and a corresponding decrease of 11,364 annual responses (currently approved 15,527). The new estimated totals are 220,658 hours and 4,163 annual responses. We attribute this adjustment to the removal of the majority tobacco burden from this collection, and the number of EA submissions we received since the last extension. Dated: November 30, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26556 Filed 12-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Notices 63179
• Mail/Hand Delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, inform FDA’s RWE framework. FDA
written/paper submissions): Dockets Rockville, MD 20852. will continue to consult stakeholders
Management Staff (HFA–305), Food and FOR FURTHER INFORMATION CONTACT: through public-private partnerships,
Drug Administration, 5630 Fishers Dianne Paraoan, Center for Drug public workshops, and demonstration
Lane, Rm. 1061, Rockville, MD 20852. Evaluation and Research, Food and projects as it implements its RWE
• For written/paper comments Drug Administration, 10903 New program.
submitted to the Dockets Management Hampshire Ave., Bldg. 51, Rm. 3326,
Staff, FDA will post your comment, as II. Electronic Access
Silver Spring, MD 20993–0002, 301–
well as any attachments, except for 796–2500, dianne.paraoan@fda.hhs.gov; Persons with access to the internet
information submitted, marked and or Stephen Ripley, Center for Biologics may obtain the ‘‘Framework for the
identified, as confidential, if submitted Evaluation and Research, Food and Real-World Evidence Program’’ at
as detailed in ‘‘Instructions.’’ Drug Administration, 10903 New https://www.fda.gov/
Instructions: All submissions received Hampshire Ave., Bldg. 71, Rm. 7301, RegulatoryInformation/LawsEnfor
must include the Docket No. FDA– Silver Spring, MD 20993–0002, 240– cedbyFDA/SignificantAmendmentsto
2018–N–4000 for ‘‘Framework for a 402–7911, stephen.ripley@fda.hhs.gov. theFDCAct/21stCenturyCuresAct/
Real-World Evidence Program; ucm562475.htm.
Availability.’’ Received comments will SUPPLEMENTARY INFORMATION:
Dated: November 30, 2018.
be placed in the docket and, except for I. Background
those submitted as ‘‘Confidential Leslie Kux,
Submissions,’’ publicly viewable at FDA is establishing a public docket to Associate Commissioner for Policy.
https://www.regulations.gov or at the collect comments on its ‘‘Framework for [FR Doc. 2018–26546 Filed 12–6–18; 8:45 am]
Dockets Management Staff between 9 a Real-World Evidence Program.’’ BILLING CODE 4164–01–P
a.m. and 4 p.m., Monday through Section 3022 of the Cures Act amended
Friday. the FD&C Act to add section 505F,
• Confidential Submissions—To Utilizing real world evidence (21 U.S.C. DEPARTMENT OF HEALTH AND
submit a comment with confidential 355g). This section requires the HUMAN SERVICES
information that you do not wish to be establishment of a program to evaluate
made publicly available, submit your the potential use of RWE to help Food and Drug Administration
comments only as a written/paper support the approval of a new
indication for a drug approved under [Docket No. FDA–2012–N–0961]
submission. You should submit two
copies total. One copy will include the section 505(c) of the FD&C Act (21
U.S.C. 355(c)) and to help to support or Agency Information Collection
information you claim to be confidential Activities; Submission for Office of
with a heading or cover note that states satisfy postapproval study requirements.
This section also requires FDA publish Management and Budget Review;
‘‘THIS DOCUMENT CONTAINS Comment Request; Environmental
CONFIDENTIAL INFORMATION.’’ The a framework for that program. In
addition to drug and biological products Impact Considerations
Agency will review this copy, including
the claimed confidential information, in approved under section 505(c) of the AGENCY: Food and Drug Administration,
its consideration of comments. The FD&C Act, FDA is also applying this HHS.
second copy, which will have the framework to biological products
ACTION: Notice.
claimed confidential information licensed under section 351 of the Public
redacted/blacked out, will be available Health Service Act (42 U.S.C. 262). SUMMARY: The Food and Drug
for public viewing and posted on The statute directs that the framework Administration (FDA) is announcing
https://www.regulations.gov. Submit for the RWE program include that a proposed collection of
both copies to the Dockets Management information describing sources of RWE, information has been submitted to the
Staff. If you do not wish your name and gaps in data collection activities, Office of Management and Budget
contact information to be made publicly standards and methodologies for (OMB) for review and clearance under
available, you can provide this collecting and analyzing RWE, and the Paperwork Reduction Act of 1995.
information on the cover sheet and not priority areas, remaining challenges, DATES: Fax written comments on the
in the body of your comments and you and potential pilot opportunities to collection of information by January 7,
must identify this information as address the overarching Cures Act 2019.
‘‘confidential.’’ Any information marked requirements. To help meet a
ADDRESSES: To ensure that comments on
as ‘‘confidential’’ will not be disclosed requirement in the Cures Act for
consultation in developing the program the information collection are received,
except in accordance with 21 CFR 10.20
framework, on September 13, 2017, OMB recommends that written
and other applicable disclosure law. For
through its cooperative agreement with comments be faxed to the Office of
more information about FDA’s posting
the Duke Margolis Center for Health Information and Regulatory Affairs,
of comments to public dockets, see 80
Policy, FDA convened a public meeting OMB, Attn: FDA Desk Officer, Fax: 202–
FR 56469, September 18, 2015, or access
that explored the use of RWE for 395–7285, or emailed to oira_
the information at: https://www.gpo.gov/
regulatory decisions. Representatives submission@omb.eop.gov. All
fdsys/pkg/FR-2015-09-18/pdf/2015-
from industry, academia, and patient comments should be identified with the
23389.pdf.
Docket: For access to the docket to advocacy groups discussed, among OMB control number 0910–0322. Also
read background documents or the other things, opportunities and include the FDA docket number found
in brackets in the heading of this
amozie on DSK3GDR082PROD with NOTICES
electronic and written/paper comments challenges associated with applying
received, go to https:// real-world data and RWE, the evidence document.
www.regulations.gov and insert the derived from that data, to demonstrate FOR FURTHER INFORMATION CONTACT:
docket number, found in brackets in the product effectiveness, including data Amber Sanford, Office of Operations,
heading of this document, into the acquisition, study design, and analytic Food and Drug Administration, Three
‘‘Search’’ box and follow the prompts methods necessary to establish causal White Flint North, 10A–12M, 11601
and/or go to the Dockets Management inference. The workshop helped to Landsdown St., North Bethesda, MD
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![63182 Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Notices
is covered under already existing approved under OMB control number of 1 application for environmental
information collections. To avoid 0910–0684. assessment. Based on FDA’s experience,
double counting, the agency has FDA’s estimates are based on actual previous information provided by
removed the burden which is approved report data from fiscal year (FY) 2015 to potential sponsors and knowledge that
under other FDA information FY 2017, on average FDA estimated it part of the EA information has already
collections. The burden for SEs are received approximately 27 modified risk been produced in one of the tobacco
currently approved under OMB control tobacco product applications (MRTPAs) product applications, FDA estimates
number 0910–0673; the burden for from 27 respondents. Based on updated that it takes approximately 80 hours to
PMTAs are currently approved under data for this collection, FDA estimates prepare an EA.
OMB control number 0910–0768; the 27 EAs from 27 respondents. A total of
burden for SE exemptions are currently 27 respondents will submit an average
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
25.40(a) and (c) ................................................................... 27 1 27 80 2,160
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The Estimated Annual Reporting Management and Budget (OMB) for professionals who serve them. F2F HICs
Burden for Human Foods is no longer a review and approval. Comments are staffed by families of CYSHCN who
part of this information collection. The submitted during the first public review have first-hand knowledge using health
burden has now been incorporated into of this ICR will be provided to OMB. care services and programs. With this
OMB control number 0910–0541. OMB will accept further comments from experience, these staff are uniquely
Our estimated burden for the the public during the review and positioned to provide support to other
information collection reflects an approval period. CYSHCN families and help other
overall decrease of 10,566 hours DATES: Comments on this ICR must be families like theirs navigate an often
(currently approved 231,224) and a received no later than January 7, 2019. complex and confusing health care and
corresponding decrease of 11,364 ADDRESSES: Submit your comments to social service system. They also serve as
annual responses (currently approved paperwork@hrsa.gov or mail the HRSA mentors and as a reliable source of
15,527). The new estimated totals are Information Collection Clearance health care information to other
220,658 hours and 4,163 annual Officer, Room 14N136B, 5600 Fishers families.
responses. We attribute this adjustment Lane, Rockville, MD 20857. During Fiscal Years (FY) 2003 to
to the removal of the majority tobacco 2017, HRSA’s Maternal and Child
FOR FURTHER INFORMATION CONTACT: To
burden from this collection, and the request more information on the Health Bureau (MCHB) awarded
number of EA submissions we received proposed project or to obtain a copy of approximately $4.9 million per FY in
since the last extension. the data collection plans and draft grants to support 51 F2F HICs in each
Dated: November 30, 2018. instruments, email paperwork@hrsa.gov of the 50 states and the District of
Leslie Kux, or call Lisa Wright-Solomon, the HRSA Columbia. In FY 2017, 49 centers that
Associate Commissioner for Policy. Information Collection Clearance Officer reported data served and trained over
[FR Doc. 2018–26556 Filed 12–6–18; 8:45 am] at (301) 443–1984. 184,000 families and approximately
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: When 85,500 health professionals. For FYs
submitting comments or requesting 2018 and 2019, HRSA MCHB will award
information, please include the approximately $6 million per FY to
DEPARTMENT OF HEALTH AND information request collection title for support 59 F2F HICs: One each in the
HUMAN SERVICES reference, in compliance with Section 50 states and the District of Columbia,
3506(c)(2)(A) of the Paperwork 1 each in the 5 U.S. Territories
Health Resources and Services Reduction Act of 1995. (American Samoa, Guam, Puerto Rico,
Administration Information Collection Request Title: the Northern Mariana Islands and the
Family-to-Family Health Information U.S. Virgin Islands), and 3 to serve
Agency Information Collection Center Feedback Surveys, OMB Control American Indians/Alaska Natives.
Activities: Submission to OMB for Number: 0906–xxxx–New. HRSA has developed feedback
Review and Approval; Public Comment Abstract: The Family-to-Family surveys to determine the extent to
Request; Information Collection Health Information Center (F2F HIC) which F2F HICs provide service to
Request Title: Family-to-Family Health program is authorized by the Social families of CYSHCN and health
Information Center Feedback Surveys, Security Act, Title V, § 501(c) (42 U.S.C. professionals who serve such families.
OMB Number: 0906–xxxx–New 701(c)), as amended by § 50501 of the Each F2F HIC will administer the
AGENCY: Health Resources and Services Bipartisan Budget Act of 2018 (Pub. L. surveys and report data back to HRSA.
Administration (HRSA), Department of 115–123). The goal of the F2F HIC Survey respondents will be asked to
amozie on DSK3GDR082PROD with NOTICES
Health and Human Services (HHS). program is to promote optimal health answer questions about how useful they
ACTION: Notice. for children and youth with special found the information, assistance, or
health care needs (CYSHCN) by resources received from the F2F HICs.
SUMMARY: In compliance with the facilitating their access to an effective The purpose of this notice is to solicit
Paperwork Reduction Act of 1995, health delivery system and by meeting comments regarding the proposed
HRSA submitted an Information the health information and support feedback surveys and the F2F HIC grant
Collection Request (ICR) to the Office of needs of families of CYSHCN and the recipient activity instructions form.
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Document Created: 2018-12-07 01:53:06
Document Modified: 2018-12-07 01:53:06
| 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 | Fax written comments on the collection of information by January 7, 2019. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 63179 |
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