81 FR 15729 - Agency Information Collection Activities; Proposed Collection; 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 81, Issue 57 (March 24, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 57 (March 24, 2016)
| Page Range | 15729-15732 | |
| FR Document | 2016-06711 |
[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)] [Notices] [Pages 15729-15732] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-06711] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0961] Agency Information Collection Activities; Proposed Collection; 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 (the PRA). DATES: Fax written comments on the collection of information by April 25, 2016. 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. [[Page 15730]] FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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--21 CFR Part 25 OMB Control Number 0910-0322--Extension 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 statues 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 September 8, 2015 (80 FR 53807), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: 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)(c), 314.50(d)(1)(iii), and 314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(c), 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 3,677 INDs from 2,501 sponsors; 120 NDAs from 87 applicants; 2,718 supplements to NDAs from 399 applicants; 9 biologic license applications (BLAs) from 8 applicants; 317 supplements to BLAs from 43 applicants; 1,475 ANDAs from 300 applicants; and 5,448 supplements to ANDAs from 318 applicants. FDA estimates that it receives approximately 13,663 claims for categorical exclusions as required under Sec. 25.15(a) and (d), and 11 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)................ 3,416 4 13,664 8 109,312 25.40(a) and (c)................ 11 1 11 3,400 37,400 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 146,712 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Estimated Annual Reporting Burden for Human Foods Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive petitions, color additive petitions, requests from exemption from regulation as a food additive, and submission of a food contact notification for a food contact substance 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 97 industry submissions. FDA received an annual average of 42 claims of categorical exclusions as required under Sec. 25.15(a) and (d) and 33 EAs as required under Sec. 25.40(a) and (c). FDA estimates that approximately 42 respondents will submit an average of 1 application for categorical exclusion and 33 respondents will submit an average of 1 EA. FDA estimates that, on average, it takes petitioners, notifiers, or [[Page 15731]] requestors approximately 8 hours to prepare a claim of categorical exclusion and approximately 210 hours to prepare an EA. Table 2--Estimated Annual Reporting Burden for Human Foods \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- 25.15(a) and (d)................................................... 42 1 42 8 336 25.40(a) and (c)................................................... 33 1 33 210 6,930 ------------------------------------------------------------------------------------ Total.......................................................... ............... ............... ............... ............... 7,266 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. 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 2012 to 2014, FDA received an average of 39 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 39 respondents will submit an average of 1 application for 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 3--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)................ 39 1 39 6 234 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. 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 4--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. 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 21 CFR 571.1(c) food additive petitions must contain a claim for categorical exclusion under Sec. 25.30 or Sec. 25.33 or an EA under Sec. 25.40. Annually, FDA's Center for Veterinary Medicine has received approximately 698 claims for categorical exclusion as required under Sec. 25.15(a) and (d), and 10 EAs as required under Sec. 25.40(a) and (c). FDA estimates that approximately 70 respondents will submit an average of 10 applications for categorical exclusion and 10 respondents will submit an average of 1 EA. FDA estimates that it takes sponsors/applicants approximately 3 hours to prepare a claim of categorical [[Page 15732]] exclusion and an average of 2,160 hours to prepare an EA. Table 5--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)................ 70 10 700 3 2,100 25.40(a) and (c)................ 10 1 10 2,160 21,600 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 23,700 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. 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. In 2015, FDA estimated it will receive approximately 5 premarket reviews of new tobacco PMTAs from 5 respondents, 509 reports intended to demonstrate the substantial equivalence of a new tobacco product (SEs) from 509 respondents, 15 exemptions from substantial equivalence requirements applications (SE Exemptions) from 15 respondents, and 3 modified risk tobacco product applications (MRTPAs) from 3 respondents. FDA is not accepting claims for categorical exclusions at this time, and estimates that there will be 532 EAs from 532 respondents as required under Sec. Sec. 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 532 respondents will submit an average of 1 application for environmental assessment. Part of the information in the EA will be developed while writing other parts of a PMTA, SE, Exemption from SE, or MRTPA. 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 6--Estimated Annual Reporting Burden for Tobacco Products \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- 25.40(a) and (c)................................................... 532 1 532 80 42,560 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-06711 Filed 3-23-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices 15729
Drug Administration, 10903 New Act to a legally marketed device that IV. Reference
Hampshire Ave., Bldg. 66, Rm. 4552, does not require premarket approval. The following reference is on display
Silver Spring, MD 20993–0002, 301– On November 21, 1997, the President in the Division of Dockets Management
796–8774, anahita.loloeimarsal@ signed into law FDAMA (Pub. L. 105– (see ADDRESSES) and is available for
fda.hhs.gov. 115). Section 206 of FDAMA, in part, viewing by interested persons between
added a new section, 510(m), to the 9 a.m. and 4 p.m., Monday through
SUPPLEMENTARY INFORMATION:
FD&C Act. Section 510(m)(1) of the Friday; it is also available electronically
I. Statutory Background FD&C Act requires FDA, within 60 days at http://www.regulations.gov. FDA has
after enactment of FDAMA, to publish verified the Web site address, as of the
Under section 513 of the Federal in the Federal Register a list of each date this document publishes in the
Food, Drug, and Cosmetic Act (the type of class II device that does not Federal Register, but Web sites are
FD&C Act) (21 U.S.C. 360c), FDA must require a report under section 510(k) of subject to change over time.
classify devices into one of three the FD&C Act to provide reasonable
regulatory classes: Class I, class II, or 1. ‘‘Procedures for Class II Device
assurance of safety and effectiveness. Exemptions from Premarket Notification,
class III. FDA classification of a device Section 510(m) of the FD&C Act further Guidance for Industry and CDRH Staff,’’
is determined by the amount of provides that a 510(k) will no longer be February 1998, available at http://
regulation necessary to provide a required for these devices upon the date www.fda.gov/downloads/
reasonable assurance of safety and of publication of the list in the Federal MedicalDevices/
effectiveness. Under the Medical Device Register. FDA published that list in the DeviceRegulationandGuidance/
Amendments of 1976 (1976 Federal Register of January 21, 1998 (63 GuidanceDocuments/UCM080199.pdf.
amendments) (Pub. L. 94–295), as FR 3142). Dated: March 17, 2016.
amended by the Safe Medical Devices Section 510(m)(2) of the FD&C Act Leslie Kux,
Act of 1990 (Pub. L. 101–629), devices provides that 1 day after date of Associate Commissioner for Policy.
are to be classified into class I (general publication of the list under section [FR Doc. 2016–06709 Filed 3–23–16; 8:45 am]
controls) if there is information showing 510(m)(1), FDA may exempt a device on
that the general controls of the FD&C BILLING CODE 4164–01–P
its own initiative or upon petition of an
Act are sufficient to assure safety and interested person if FDA determines
effectiveness; into class II (special that a 510(k) is not necessary to provide DEPARTMENT OF HEALTH AND
controls) if general controls, by reasonable assurance of the safety and HUMAN SERVICES
themselves, are insufficient to provide effectiveness of the device. This section
reasonable assurance of safety and requires FDA to publish in the Federal Food and Drug Administration
effectiveness, but there is sufficient Register a notice of intent to exempt a
information to establish special controls [Docket No. FDA–2012–N–0961]
device, or of the petition, and to provide
to provide such assurance; and into a 30-day comment period. Within 120
class III (premarket approval) if there is Agency Information Collection
days of publication of this document, Activities; Proposed Collection;
insufficient information to support FDA must publish in the Federal
classifying a device into class I or class Submission for Office of Management
Register its final determination and Budget Review; Comment
II and the device is a life sustaining or regarding the exemption of the device
life supporting device, or is for a use Request; Environmental Impact
that was the subject of the notice. If FDA Considerations
which is of substantial importance in fails to respond to a petition under this
preventing impairment of human health section within 180 days of receiving it, AGENCY: Food and Drug Administration,
or presents a potential unreasonable risk the petition shall be deemed granted. HHS.
of illness or injury. ACTION: Notice.
II. Criteria for Exemption
Most generic types of devices that
were on the market before the date of There are a number of factors FDA SUMMARY: The Food and Drug
the 1976 amendments (May 28, 1976) may consider to determine whether a Administration (FDA) is announcing
(generally referred to as preamendments 510(k) is necessary to provide that a proposed collection of
devices) have been classified by FDA reasonable assurance of the safety and information has been submitted to the
under the procedures set forth in section effectiveness of a class II device. These Office of Management and Budget
513(c) and (d) of the FD&C Act through factors are discussed in the guidance the (OMB) for review and clearance under
the issuance of classification regulations Agency issued on February 19, 1998, the Paperwork Reduction Act of 1995
into one of these three regulatory entitled ‘‘Procedures for Class II Device (the PRA).
classes. Devices introduced into Exemptions from Premarket DATES: Fax written comments on the
interstate commerce for the first time on Notification, Guidance for Industry and collection of information by April 25,
or after May 28, 1976 (generally referred CDRH Staff’’ (Ref. 1). 2016.
to as postamendments devices), are ADDRESSES: To ensure that comments on
III. Proposed Class II Device
classified through the premarket the information collection are received,
Exemptions
notification process under section OMB recommends that written
510(k) of the FD&C Act (21 U.S.C. FDA has received the following comments be faxed to the Office of
360(k)). Section 510(k) of the FD&C Act petition requesting an exemption from Information and Regulatory Affairs,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
and the implementing regulations, 21 premarket notification for a class II OMB, Attn: FDA Desk Officer, FAX:
CFR part 807, require persons who device: Evelyn Mirza, Biorex Labs, LLC, 202–395–7285, or emailed to oira_
intend to market a new device to submit 194 E. Wallings Rd., Suite 201, submission@omb.eop.gov. All
a premarket notification (510(k)) Broadview Heights, OH 44147 for its comments should be identified with the
containing information that allows FDA method, metallic reduction, glucose OMB control number 0910–0322. Also
to determine whether the new device is (urinary, non-quantitative) test system include the FDA docket number found
‘‘substantially equivalent’’ within the in a reagent tablet format classified in brackets in the heading of this
meaning of section 513(i) of the FD&C under 21 CFR 862.1340. document.
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![15732 Federal Register / Vol. 81, No. 57 / Thursday, March 24, 2016 / Notices
exclusion and an average of 2,160 hours
to prepare an EA.
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
25.15(a) and (d) ................................................................... 70 10 700 3 2,100
25.40(a) and (c) ................................................................... 10 1 10 2,160 21,600
Total .............................................................................. ........................ ........................ ........................ ........................ 23,700
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for demonstrate the substantial equivalence approximately 532 respondents will
Tobacco Products of a new tobacco product (SEs) from 509 submit an average of 1 application for
respondents, 15 exemptions from environmental assessment. Part of the
Under sections 905, 910, and 911 of substantial equivalence requirements information in the EA will be developed
the Federal Food, Drug, and Cosmetic applications (SE Exemptions) from 15 while writing other parts of a PMTA,
Act (21 U.S.C. 387e, 387j, and 387k), respondents, and 3 modified risk SE, Exemption from SE, or MRTPA.
product applications and supplements tobacco product applications (MRTPAs) Based on FDA’s experience, previous
(PMTAs), SEs, Exemption from SEs, and from 3 respondents. FDA is not information provided by potential
modified risk tobacco products must accepting claims for categorical sponsors and knowledge that part of the
contain a claim for categorical exclusion exclusions at this time, and estimates EA information has already been
or an EA. In 2015, FDA estimated it will that there will be 532 EAs from 532 produced in one of the tobacco product
receive approximately 5 premarket respondents as required under applications, FDA estimates that it takes
reviews of new tobacco PMTAs from 5 §§ 25.40(a) and (c). Therefore, over the approximately 80 hours to prepare an
respondents, 509 reports intended to next 3 years, FDA estimates that EA.
TABLE 6—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) ................................................................... 532 1 532 80 42,560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 18, 2016. Management and Budget (OMB) for Abstract: Office of Minority Health
Leslie Kux, review and approval. The ICR is for (OMH) in the Office of the Assistant
Associate Commissioner for Policy. renewal of the approved information Secretary for Health (OASH), Office of
[FR Doc. 2016–06711 Filed 3–23–16; 8:45 am] collection assigned OMB control the Secretary (OS) is requesting
BILLING CODE 4164–01–P
number 0990–0406, scheduled to expire approval for an extension from the
on April 30, 2016. Comments submitted Office of Management and Budget
during the first public review of this ICR (OMB) for a previously approved data
DEPARTMENT OF HEALTH AND will be provided to OMB. OMB will collection activity for the Evaluation of
HUMAN SERVICES accept further comments from the the National Partnership for Action to
public on this ICR during the review End Health Disparities (NPA). The NPA
Office of the Secretary and approval period. was officially launched in April 2011 to
DATES: Comments on the ICR must be mobilize a nationwide, comprehensive,
[Document Identifier: HHS–OS–0990–0406 community-driven, and sustained
received on or before April 25, 2016.
30D] approach to combating health
ADDRESSES: Submit your comments to
disparities and to move the nation
Agency Information Collection OIRA_submission@omb.eop.gov or via
toward achieving health equity. Using
Activities; Submission to OMB for facsimile to (202) 395–5806.
an approach that vests those at the front
Review and Approval; Public Comment FOR FURTHER INFORMATION CONTACT: line with the responsibility of
Request Information Collection Clearance staff, identifying and helping to shape core
AGENCY: Office of the Secretary, HHS. Information.CollectionClearance@ actions, new approaches and new
hhs.gov or (202) 690–6162. partnerships are being established to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ACTION: Notice.
SUPPLEMENTARY INFORMATION: When help close the health gap in the United
SUMMARY: In compliance with section submitting comments or requesting States.
3507(a)(1)(D) of the Paperwork information, please include the OMB OMH proposes to continue to conduct
Reduction Act of 1995, the Office of the control number 0990–0406 for the evaluation of the NPA. The
Secretary (OS), Department of Health reference. evaluation’s goal is to determine the
and Human Services, has submitted an Information Collection Request Title: extent to which the NPA has
Information Collection Request (ICR), Evaluation of the National Partnership contributed to the elimination of health
described below, to the Office of for Action to End Health Disparities disparities and attainment of health
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Document Created: 2016-03-24 00:57:29
Document Modified: 2016-03-24 00:57:29
| 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 April 25, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 15729 |
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